ID

44695

Description

ODM derived from http://clinicaltrials.gov/show/NCT01241448

Link

http://clinicaltrials.gov/show/NCT01241448

Keywords

Versions (3)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01241448 Diabetes Mellitus, Type 2

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
Description

Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*1
C0011860
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Description

Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0015787
SNOMED CT 2011_0131
169549004
MedDRA 14.1
10056199
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0278321
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
UMLS CUI 2011AA
C0520483
SNOMED CT 2011_0131
77543007
MedDRA 14.1
10044722
UMLS CUI 2011AA
C0025320
SNOMED CT 2011_0131
161712005
MedDRA 14.1
10027308
CTCAE 1105E
E13750
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
Description

Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.
Description

Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.

Data type

boolean

Alias
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
Have an HbA1c value of 7.0% to 10.5% , inclusive.
Description

Have an HbA1c value of 7.0% to 10.5% , inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C1522609
Body mass index
Description

Have a body mass index (BMI) between 25 to 45 kg/m2, inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
In the opinion of the investigator, are capable and willing to:
Description

In the opinion of the investigator, are capable and willing to:

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C2698977
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
Perform self-monitoring of blood glucose
Description

Perform self-monitoring of blood glucose

Data type

boolean

Alias
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
Complete a study diary as required for this protocol
Description

Complete a study diary as required for this protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0376660
UMLS CUI 2011AA
C1709747
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
Description

Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0026606
SNOMED CT 2011_0131
68130003
LOINC Version 232
MTHU017278
UMLS CUI 2011AA
C0474396
SNOMED CT 2011_0131
401175000, 404950004
Comply with treatment regimens
Description

Comply with treatment regimens

Data type

boolean

Alias
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
UMLS CUI 2011AA
CL031856
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
Description

Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
Description

Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0020615
SNOMED CT 2011_0131
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0007004
SNOMED CT 2011_0131
350544001
LOINC Version 232
MTHU006866
UMLS CUI 2011AA
C0017687
SNOMED CT 2011_0131
10712001
LOINC Version 232
MTHU005175
UMLS CUI 2011AA
C0035273
SNOMED CT 2011_0131
439569004
MedDRA 14.1
10038749
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0342317
MedDRA 14.1
10020997
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Description

Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C1546435
HL7 V3 2006_05
ER
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C2700379
UMLS CUI 2011AA
C0726398
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
Description

Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.

Data type

boolean

Alias
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C0017127
UMLS CUI 2011AA
C0232572
SNOMED CT 2011_0131
36735000
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0017125
SNOMED CT 2011_0131
442338001
MedDRA 14.1
10061966
UMLS CUI 2011AA
C1960832
MedDRA 14.1
10060785
UMLS CUI 2011AA
C0038895
Have had a previous diagnosis of pancreatitis.
Description

Have had a previous diagnosis of pancreatitis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0030305
SNOMED CT 2011_0131
75694006
MedDRA 14.1
10033645
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577.0
CTCAE 1105E
E10930
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
Description

Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure

Data type

boolean

Alias
UMLS CUI 2011AA
C1275491
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
Description

Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0877341
MedDRA 14.1
10049887
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
Description

Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0039240
SNOMED CT 2011_0131
6456007
MedDRA 14.1
10042604
ICD-10-CM Version 2010
I47.1
CTCAE 1105E
E10218
UMLS CUI 2011AA
C0042514
SNOMED CT 2011_0131
25569003
MedDRA 14.1
10047302
ICD-10-CM Version 2010
I47.2
CTCAE 1105E
E10239
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
Description

Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.
Description

Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
Show evidence of labile blood pressure, including symptomatic postural hypotension.
Description

Show evidence of labile blood pressure, including symptomatic postural hypotension.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0428895
SNOMED CT 2011_0131
251080003
MedDRA 14.1
10023533
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0020651
SNOMED CT 2011_0131
28651003
MedDRA 14.1
10031127
ICD-10-CM Version 2010
I95.1
ICD-9-CM Version 2011
458.0
Have any abnormality of the ECG that would impact patient safety or data interpretation.
Description

Have any abnormality of the ECG that would impact patient safety or data interpretation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0522055
SNOMED CT 2011_0131
102594003
MedDRA 14.1
10014363
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C1511726
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
Description

Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0877359
MedDRA 14.1
10048557
UMLS CUI 2011AA
C2825579
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Have a current or previous diagnosis of Gilbert's disease.
Description

Have a current or previous diagnosis of Gilbert's disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
Have previous or current diagnosis of Hepatitis B or C
Description

Have previous or current diagnosis of Hepatitis B or C

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
Description

Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
Description

Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205202
SNOMED CT 2011_0131
33714007
UMLS CUI 2011AA
C0020676
SNOMED CT 2011_0131
40930008
MedDRA 14.1
10021114
LOINC Version 232
MTHU020783
ICD-10-CM Version 2010
E03.9
ICD-9-CM Version 2011
244.9
CTCAE 1105E
E10334
UMLS CUI 2011AA
C0020550
SNOMED CT 2011_0131
34486009
MedDRA 14.1
10020850
LOINC Version 232
MTHU020782
ICD-10-CM Version 2010
E05.9
ICD-9-CM Version 2011
242.9
CTCAE 1105E
E10322
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C0040160
SNOMED CT 2011_0131
65428006
LOINC Version 232
MTHU002328
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
Description

Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1879533
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0005802
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0429236
SNOMED CT 2011_0131
251396006
UMLS CUI 2011AA
C1325413
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Description

Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0687702
MedDRA 14.1
10065305
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0154088
SNOMED CT 2011_0131
92691004
MedDRA 14.1
10036912
ICD-10-CM Version 2010
D07.5
ICD-9-CM Version 2011
233.4
Have a personal or family history of pancreatic neoplasia.
Description

Have a personal or family history of pancreatic neoplasia.

Data type

boolean

Alias
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0030297
SNOMED CT 2011_0131
126859007
MedDRA 14.1
10061902
UMLS CUI 2011AA
C1997382
SNOMED CT 2011_0131
429000004
Have non-fasting triglycerides >600 mg/dL.
Description

Have non-fasting triglycerides >600 mg/dL.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347359
UMLS CUI 2011AA
C0041004
SNOMED CT 2011_0131
85600001
LOINC Version 232
MTHU003166
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
Description

Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0240016
SNOMED CT 2011_0131
246491008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2916791
UMLS CUI 2011AA
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
Description

Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0013231
SNOMED CT 2011_0131
329505003, 80288002
UMLS CUI 2011AA
CL425124
UMLS CUI 2011AA
C1572271
UMLS CUI 2011AA
C1874587
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
Description

Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
CL428886
MedDRA 14.1
10071104
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C0360289
SNOMED CT 2011_0131
350088003
UMLS CUI 2011AA
C0556393
SNOMED CT 2011_0131
228376009
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.
Description

Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0020456
SNOMED CT 2011_0131
80394007
MedDRA 14.1
10020635
ICD-10-CM Version 2010
R73.9
CTCAE 1105E
E12276
UMLS CUI 2011AA
C0020615
SNOMED CT 2011_0131
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
UMLS CUI 2011AA
C0360701
SNOMED CT 2011_0131
373278006
UMLS CUI 2011AA
C0360703
SNOMED CT 2011_0131
372855004
UMLS CUI 2011AA
C0017184
UMLS CUI 2011AA
C0002763
SNOMED CT 2011_0131
349897000
UMLS CUI 2011AA
C1449704
UMLS CUI 2011AA
C0027996
SNOMED CT 2011_0131
273943001
LOINC Version 232
MTHU002113
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0678438
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).
Description

Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).

Data type

boolean

Alias
UMLS CUI 2011AA
C1510992
UMLS CUI 2011AA
C0332174
SNOMED CT 2011_0131
14497002
UMLS CUI 2011AA
C0560219
SNOMED CT 2011_0131
160592001
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0004922
SNOMED CT 2011_0131
53410008
UMLS CUI 2011AA
C0043188
SNOMED CT 2011_0131
35748005
UMLS CUI 2011AA
C0301611
SNOMED CT 2011_0131
6524003
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
CL407604
UMLS CUI 2011AA
C0678793
UMLS CUI 2011AA
C0012265
SNOMED CT 2011_0131
796001
LOINC Version 232
MTHU001808
UMLS CUI 2011AA
C0023870
SNOMED CT 2011_0131
85899009
LOINC Version 232
MTHU004197
UMLS CUI 2011AA
C0031507
SNOMED CT 2011_0131
40556005
LOINC Version 232
MTHU002993
UMLS CUI 2011AA
C0039771
SNOMED CT 2011_0131
372810006
LOINC Version 232
MTHU004269
UMLS CUI 2011AA
C0043031
SNOMED CT 2011_0131
48603004
LOINC Version 232
MTHU003212
Currently use drugs that are known to prolong the QT interval.
Description

Currently use drugs that are known to prolong the QT interval.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
Description

Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0059563
SNOMED CT 2011_0131
424790003
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C1145759
SNOMED CT 2011_0131
413591007
LOINC Version 232
MTHU018644
UMLS CUI 2011AA
C0376637
SNOMED CT 2011_0131
108695003
LOINC Version 232
MTHU013846
UMLS CUI 2011AA
C0525005
SNOMED CT 2011_0131
108706004
LOINC Version 232
MTHU013848
UMLS CUI 2011AA
C0292818
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
UMLS CUI 2011AA
C0055856
SNOMED CT 2011_0131
83999008
LOINC Version 232
MTHU006897
UMLS CUI 2011AA
C0064113
SNOMED CT 2011_0131
387532006
LOINC Version 232
MTHU002298
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C0068485
SNOMED CT 2011_0131
108435006
LOINC Version 232
MTHU003461
UMLS CUI 2011AA
C0286738
SNOMED CT 2011_0131
108700005
LOINC Version 232
MTHU008513
UMLS CUI 2011AA
C1452484
SNOMED CT 2011_0131
395260006
LOINC Version 232
MTHU016681
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
Description

Have previously completed or withdrawn from this study or any other study investigating LY2409021.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C2349954
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Have known allergies to LY2409021 or related compounds.
Description

Have known allergies to LY2409021 or related compounds.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0205198
SNOMED CT 2011_0131
62105006
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Description

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Data type

boolean

Alias
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0079816
UMLS CUI 2011AA
C0679426
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
Description

Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
Item
Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
boolean
C0011900 (UMLS CUI 1)
C0011860 (UMLS CUI 1*1)
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Item
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
C0520483 (UMLS CUI 2011AA)
77543007 (SNOMED CT 2011_0131)
10044722 (MedDRA 14.1)
C0025320 (UMLS CUI 2011AA)
161712005 (SNOMED CT 2011_0131)
10027308 (MedDRA 14.1)
E13750 (CTCAE 1105E)
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
Item
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.
Item
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.
boolean
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Have an HbA1c value of 7.0% to 10.5% , inclusive.
Item
Have an HbA1c value of 7.0% to 10.5% , inclusive.
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Have a body mass index (BMI) between 25 to 45 kg/m2, inclusive.
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
In the opinion of the investigator, are capable and willing to:
Item
In the opinion of the investigator, are capable and willing to:
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
Perform self-monitoring of blood glucose
Item
Perform self-monitoring of blood glucose
boolean
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
Complete a study diary as required for this protocol
Item
Complete a study diary as required for this protocol
boolean
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
Item
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
boolean
C0024501 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0026606 (UMLS CUI 2011AA)
68130003 (SNOMED CT 2011_0131)
MTHU017278 (LOINC Version 232)
C0474396 (UMLS CUI 2011AA)
401175000, 404950004 (SNOMED CT 2011_0131)
Comply with treatment regimens
Item
Comply with treatment regimens
boolean
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
Item
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
Item
Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
boolean
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0007004 (UMLS CUI 2011AA)
350544001 (SNOMED CT 2011_0131)
MTHU006866 (LOINC Version 232)
C0017687 (UMLS CUI 2011AA)
10712001 (SNOMED CT 2011_0131)
MTHU005175 (LOINC Version 232)
C0035273 (UMLS CUI 2011AA)
439569004 (SNOMED CT 2011_0131)
10038749 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0342317 (UMLS CUI 2011AA)
10020997 (MedDRA 14.1)
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Item
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
boolean
C1546435 (UMLS CUI 2011AA)
ER (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C2700379 (UMLS CUI 2011AA)
C0726398 (UMLS CUI 2011AA)
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
Item
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
boolean
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0017127 (UMLS CUI 2011AA)
C0232572 (UMLS CUI 2011AA)
36735000 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0017125 (UMLS CUI 2011AA)
442338001 (SNOMED CT 2011_0131)
10061966 (MedDRA 14.1)
C1960832 (UMLS CUI 2011AA)
10060785 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
Have had a previous diagnosis of pancreatitis.
Item
Have had a previous diagnosis of pancreatitis.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
Item
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
boolean
C1275491 (UMLS CUI 2011AA)
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
Item
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0877341 (UMLS CUI 2011AA)
10049887 (MedDRA 14.1)
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
Item
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0039240 (UMLS CUI 2011AA)
6456007 (SNOMED CT 2011_0131)
10042604 (MedDRA 14.1)
I47.1 (ICD-10-CM Version 2010)
E10218 (CTCAE 1105E)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
Item
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.
Item
Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
Show evidence of labile blood pressure, including symptomatic postural hypotension.
Item
Show evidence of labile blood pressure, including symptomatic postural hypotension.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0428895 (UMLS CUI 2011AA)
251080003 (SNOMED CT 2011_0131)
10023533 (MedDRA 14.1)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0020651 (UMLS CUI 2011AA)
28651003 (SNOMED CT 2011_0131)
10031127 (MedDRA 14.1)
I95.1 (ICD-10-CM Version 2010)
458.0 (ICD-9-CM Version 2011)
Have any abnormality of the ECG that would impact patient safety or data interpretation.
Item
Have any abnormality of the ECG that would impact patient safety or data interpretation.
boolean
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C1511726 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
Item
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
boolean
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0877359 (UMLS CUI 2011AA)
10048557 (MedDRA 14.1)
C2825579 (UMLS CUI 2011AA)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Have a current or previous diagnosis of Gilbert's disease.
Item
Have a current or previous diagnosis of Gilbert's disease.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
Have previous or current diagnosis of Hepatitis B or C
Item
Have previous or current diagnosis of Hepatitis B or C
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
Item
Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
Item
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
C0020676 (UMLS CUI 2011AA)
40930008 (SNOMED CT 2011_0131)
10021114 (MedDRA 14.1)
MTHU020783 (LOINC Version 232)
E03.9 (ICD-10-CM Version 2010)
244.9 (ICD-9-CM Version 2011)
E10334 (CTCAE 1105E)
C0020550 (UMLS CUI 2011AA)
34486009 (SNOMED CT 2011_0131)
10020850 (MedDRA 14.1)
MTHU020782 (LOINC Version 232)
E05.9 (ICD-10-CM Version 2010)
242.9 (ICD-9-CM Version 2011)
E10322 (CTCAE 1105E)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0040160 (UMLS CUI 2011AA)
65428006 (SNOMED CT 2011_0131)
MTHU002328 (LOINC Version 232)
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
Item
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1879533 (UMLS CUI 2011AA)
C1704258 (UMLS CUI 2011AA)
C0005802 (UMLS CUI 2011AA)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0429236 (UMLS CUI 2011AA)
251396006 (SNOMED CT 2011_0131)
C1325413 (UMLS CUI 2011AA)
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Item
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154088 (UMLS CUI 2011AA)
92691004 (SNOMED CT 2011_0131)
10036912 (MedDRA 14.1)
D07.5 (ICD-10-CM Version 2010)
233.4 (ICD-9-CM Version 2011)
Have a personal or family history of pancreatic neoplasia.
Item
Have a personal or family history of pancreatic neoplasia.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0030297 (UMLS CUI 2011AA)
126859007 (SNOMED CT 2011_0131)
10061902 (MedDRA 14.1)
C1997382 (UMLS CUI 2011AA)
429000004 (SNOMED CT 2011_0131)
Have non-fasting triglycerides >600 mg/dL.
Item
Have non-fasting triglycerides >600 mg/dL.
boolean
C2347359 (UMLS CUI 2011AA)
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
Item
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
boolean
C0240016 (UMLS CUI 2011AA)
246491008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2916791 (UMLS CUI 2011AA)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
Item
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
CL425124 (UMLS CUI 2011AA)
C1572271 (UMLS CUI 2011AA)
C1874587 (UMLS CUI 2011AA)
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
Item
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C1299003 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0556393 (UMLS CUI 2011AA)
228376009 (SNOMED CT 2011_0131)
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.
Item
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0020456 (UMLS CUI 2011AA)
80394007 (SNOMED CT 2011_0131)
10020635 (MedDRA 14.1)
R73.9 (ICD-10-CM Version 2010)
E12276 (CTCAE 1105E)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0360701 (UMLS CUI 2011AA)
373278006 (SNOMED CT 2011_0131)
C0360703 (UMLS CUI 2011AA)
372855004 (SNOMED CT 2011_0131)
C0017184 (UMLS CUI 2011AA)
C0002763 (UMLS CUI 2011AA)
349897000 (SNOMED CT 2011_0131)
C1449704 (UMLS CUI 2011AA)
C0027996 (UMLS CUI 2011AA)
273943001 (SNOMED CT 2011_0131)
MTHU002113 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0678438 (UMLS CUI 2011AA)
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).
Item
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).
boolean
C1510992 (UMLS CUI 2011AA)
C0332174 (UMLS CUI 2011AA)
14497002 (SNOMED CT 2011_0131)
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0004922 (UMLS CUI 2011AA)
53410008 (SNOMED CT 2011_0131)
C0043188 (UMLS CUI 2011AA)
35748005 (SNOMED CT 2011_0131)
C0301611 (UMLS CUI 2011AA)
6524003 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0678793 (UMLS CUI 2011AA)
C0012265 (UMLS CUI 2011AA)
796001 (SNOMED CT 2011_0131)
MTHU001808 (LOINC Version 232)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0031507 (UMLS CUI 2011AA)
40556005 (SNOMED CT 2011_0131)
MTHU002993 (LOINC Version 232)
C0039771 (UMLS CUI 2011AA)
372810006 (SNOMED CT 2011_0131)
MTHU004269 (LOINC Version 232)
C0043031 (UMLS CUI 2011AA)
48603004 (SNOMED CT 2011_0131)
MTHU003212 (LOINC Version 232)
Currently use drugs that are known to prolong the QT interval.
Item
Currently use drugs that are known to prolong the QT interval.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
Item
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0059563 (UMLS CUI 2011AA)
424790003 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C1145759 (UMLS CUI 2011AA)
413591007 (SNOMED CT 2011_0131)
MTHU018644 (LOINC Version 232)
C0376637 (UMLS CUI 2011AA)
108695003 (SNOMED CT 2011_0131)
MTHU013846 (LOINC Version 232)
C0525005 (UMLS CUI 2011AA)
108706004 (SNOMED CT 2011_0131)
MTHU013848 (LOINC Version 232)
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0055856 (UMLS CUI 2011AA)
83999008 (SNOMED CT 2011_0131)
MTHU006897 (LOINC Version 232)
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0068485 (UMLS CUI 2011AA)
108435006 (SNOMED CT 2011_0131)
MTHU003461 (LOINC Version 232)
C0286738 (UMLS CUI 2011AA)
108700005 (SNOMED CT 2011_0131)
MTHU008513 (LOINC Version 232)
C1452484 (UMLS CUI 2011AA)
395260006 (SNOMED CT 2011_0131)
MTHU016681 (LOINC Version 232)
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
Item
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C2349954 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have known allergies to LY2409021 or related compounds.
Item
Have known allergies to LY2409021 or related compounds.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0205198 (UMLS CUI 2011AA)
62105006 (SNOMED CT 2011_0131)
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Item
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
C0079816 (UMLS CUI 2011AA)
C0679426 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
Item
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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