ID

44635

Description

ODM derived from http://clinicaltrials.gov/show/NCT01126580

Link

http://clinicaltrials.gov/show/NCT01126580

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - 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 NCT01126580 Diabetes Mellitus, Type 2

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).
Description

Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0679228
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).
Description

Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).

Data type

boolean

Alias
UMLS CUI 2011AA
C0919936
MedDRA 14.1
10051259
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
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
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
Description

Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0013220
SNOMED CT 2011_0131
228432001
MedDRA 14.1
10052804
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
Hemoglobin A1c (HbA1c)
Description

Have HbA1c >= 6.5% to <= 9.5%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Description

Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
a)test negative for pregnancy at screening based on a serum pregnancy test, and
Description

a)test negative for pregnancy at screening based on a serum pregnancy test, and

Data type

boolean

Alias
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C1409616
b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or
Description

b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Not Lactating
Description

c)not be breastfeeding.

Data type

boolean

Alias
UMLS CUI 2011AA
C2826207
Have a stable weight (plus or minus 5%) >= 3 months prior to screening.
Description

Have a stable weight (plus or minus 5%) >= 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
Body mass index
Description

Have a body mass index (BMI) between 23 and 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
Are well-motivated, capable, and willing to:
Description

Are well-motivated, capable, and willing to:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C0026605
SNOMED CT 2011_0131
363882003
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
a)perform SMBG testing
Description

a)perform SMBG testing

Data type

boolean

Alias
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
UMLS CUI 2011AA
C0039593
b)learn how to self-inject treatment (LY2189265 or placebo)and
Description

b)learn how to self-inject treatment (LY2189265 or placebo)and

Data type

boolean

Alias
UMLS CUI 2011AA
C0023185
SNOMED CT 2011_0131
69998004
UMLS CUI 2011AA
C0036588
UMLS CUI 2011AA
C1720154
SNOMED CT 2011_0131
422145002
UMLS CUI 2011AA
C2976495
UMLS CUI 2011AA
C0032042
c)maintain a study diary.
Description

c)maintain a study diary.

Data type

boolean

Alias
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0376660
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Diabetes Mellitus, Insulin-Dependent
Description

You have type 1 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
You are being or have been treated with any of the following medications:
Description

You are being or have been treated with any of the following medications:

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0013227
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
Description

a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
CL433252
b)GLP-1 analogs within 3 months prior to this screening,
Description

b)GLP-1 analogs within 3 months prior to this screening,

Data type

boolean

Alias
UMLS CUI 2011AA
CL430618
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
c)drugs to cause weight loss within 3 months prior to screening,
Description

c)drugs to cause weight loss within 3 months prior to screening,

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C1262477
SNOMED CT 2011_0131
89362005
MedDRA 14.1
10047895
LOINC Version 232
MTHU020881
ICD-9-CM Version 2011
783.21
CTCAE 1105E
E12228
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
d)thiazolidinediones (TZDs)within 3 months prior to screening,
Description

d)thiazolidinediones (TZDs)within 3 months prior to screening,

Data type

boolean

Alias
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
Description

e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0017710
SNOMED CT 2011_0131
419933005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Illicit Drugs
Description

f)illegal drugs.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086190
SNOMED CT 2011_0131
77657003
LOINC Version 232
MTHU035698
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
Description

You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,

Data type

boolean

Alias
UMLS CUI 2011AA
C0860161
MedDRA 14.1
10012619
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
Description

You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.

Data type

boolean

Alias
UMLS CUI 2011AA
C0577027
SNOMED CT 2011_0131
300306001
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0232459
SNOMED CT 2011_0131
61578001
MedDRA 14.1
10012980
LOINC Version 232
MTHU013235
UMLS CUI 2011AA
C0017125
SNOMED CT 2011_0131
442338001
MedDRA 14.1
10061966
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C1456587
MedDRA 14.1
10068900
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
Description

You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.

Data type

boolean

Alias
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
C0008031
SNOMED CT 2011_0131
29857009
MedDRA 14.1
10008479
LOINC Version 232
MTHU035552
ICD-10-CM Version 2010
R07.9
ICD-9-CM Version 2011
786.5
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0190211
SNOMED CT 2011_0131
41339005
MedDRA 14.1
10050329
UMLS CUI 2011AA
C0521232
SNOMED CT 2011_0131
36969009
MedDRA 14.1
10052086
ICD-9-CM Version 2011
36.06
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
Description

You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
You have a problem with your liver or pancreas.
Description

You have a problem with your liver or pancreas.

Data type

boolean

Alias
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
C0030286
SNOMED CT 2011_0131
3855007
MedDRA 14.1
10033616
ICD-10-CM Version 2010
K86.9
ICD-9-CM Version 2011
577.9
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
Description

You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0014130
SNOMED CT 2011_0131
362969004
MedDRA 14.1
10014695
LOINC Version 232
MTHU021570
ICD-10-CM Version 2010
E34.9
ICD-9-CM Version 2011
259.9
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
Description

You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0863135
SNOMED CT 2011_0131
271230004
MedDRA 14.1
10040167
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C1409616
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
Description

You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0342190
MedDRA 14.1
10070569
UMLS CUI 2011AA
C0025268
SNOMED CT 2011_0131
61808009
MedDRA 14.1
10028191
ICD-10-CM Version 2010
E31.22
ICD-9-CM Version 2011
258.02
UMLS CUI 2011AA
C0025269
SNOMED CT 2011_0131
61530001
MedDRA 14.1
10056420
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
Description

You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.

Data type

boolean

Alias
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007114
SNOMED CT 2011_0131
372130007
MedDRA 14.1
10040808
ICD-10-CM Version 2010
C44.9
UMLS CUI 2011AA
C0687702
MedDRA 14.1
10065305
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
You have had an organ transplant except for corneal transplant.
Description

You have had an organ transplant except for corneal transplant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0010042
SNOMED CT 2011_0131
60656008
MedDRA 14.1
10054846
ICD-9-CM Version 2011
11.60
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
Description

You have received treatment within the last 30 days with a drug which has not been regulatory approved.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1704735
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
Description

You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
Description

You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
Description

You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.

Data type

boolean

Alias
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0392201
SNOMED CT 2011_0131
33747003
MedDRA 14.1
10005553
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
CL423120
You have previously participated or signed an informed consent document for this same type of study and study drug.
Description

You have previously participated or signed an informed consent document for this same type of study and study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C2348583
UMLS CUI 2011AA
C0445247
SNOMED CT 2011_0131
262126009
UMLS CUI 2011AA
C0035171
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
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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
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).
Item
Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0679228 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).
Item
Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).
boolean
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (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)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
Item
Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C1524031 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Have HbA1c >= 6.5% to <= 9.5%.
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
Item
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
a)test negative for pregnancy at screening based on a serum pregnancy test, and
Item
a)test negative for pregnancy at screening based on a serum pregnancy test, and
boolean
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or
Item
b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or
boolean
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
c)not be breastfeeding.
Item
Not Lactating
boolean
C2826207 (UMLS CUI 2011AA)
Have a stable weight (plus or minus 5%) >= 3 months prior to screening.
Item
Have a stable weight (plus or minus 5%) >= 3 months prior to screening.
boolean
C0005910 (UMLS CUI 2011AA)
Have a body mass index (BMI) between 23 and 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)
Are well-motivated, capable, and willing to:
Item
Are well-motivated, capable, and willing to:
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0026605 (UMLS CUI 2011AA)
363882003 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
a)perform SMBG testing
Item
a)perform SMBG testing
boolean
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
b)learn how to self-inject treatment (LY2189265 or placebo)and
Item
b)learn how to self-inject treatment (LY2189265 or placebo)and
boolean
C0023185 (UMLS CUI 2011AA)
69998004 (SNOMED CT 2011_0131)
C0036588 (UMLS CUI 2011AA)
C1720154 (UMLS CUI 2011AA)
422145002 (SNOMED CT 2011_0131)
C2976495 (UMLS CUI 2011AA)
C0032042 (UMLS CUI 2011AA)
c)maintain a study diary.
Item
c)maintain a study diary.
boolean
C0024501 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
You have type 1 diabetes mellitus
Item
Diabetes Mellitus, Insulin-Dependent
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
You are being or have been treated with any of the following medications:
Item
You are being or have been treated with any of the following medications:
boolean
CL415147 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
Item
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
CL433252 (UMLS CUI 2011AA)
b)GLP-1 analogs within 3 months prior to this screening,
Item
b)GLP-1 analogs within 3 months prior to this screening,
boolean
CL430618 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
c)drugs to cause weight loss within 3 months prior to screening,
Item
c)drugs to cause weight loss within 3 months prior to screening,
boolean
C0013227 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1262477 (UMLS CUI 2011AA)
89362005 (SNOMED CT 2011_0131)
10047895 (MedDRA 14.1)
MTHU020881 (LOINC Version 232)
783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
d)thiazolidinediones (TZDs)within 3 months prior to screening,
Item
d)thiazolidinediones (TZDs)within 3 months prior to screening,
boolean
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
Item
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
f)illegal drugs.
Item
Illicit Drugs
boolean
C0086190 (UMLS CUI 2011AA)
77657003 (SNOMED CT 2011_0131)
MTHU035698 (LOINC Version 232)
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
Item
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
boolean
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
Item
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
boolean
C0577027 (UMLS CUI 2011AA)
300306001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0232459 (UMLS CUI 2011AA)
61578001 (SNOMED CT 2011_0131)
10012980 (MedDRA 14.1)
MTHU013235 (LOINC Version 232)
C0017125 (UMLS CUI 2011AA)
442338001 (SNOMED CT 2011_0131)
10061966 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C1456587 (UMLS CUI 2011AA)
10068900 (MedDRA 14.1)
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
Item
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
boolean
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)
C0008031 (UMLS CUI 2011AA)
29857009 (SNOMED CT 2011_0131)
10008479 (MedDRA 14.1)
MTHU035552 (LOINC Version 232)
R07.9 (ICD-10-CM Version 2010)
786.5 (ICD-9-CM Version 2011)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0190211 (UMLS CUI 2011AA)
41339005 (SNOMED CT 2011_0131)
10050329 (MedDRA 14.1)
C0521232 (UMLS CUI 2011AA)
36969009 (SNOMED CT 2011_0131)
10052086 (MedDRA 14.1)
36.06 (ICD-9-CM Version 2011)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
Item
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
You have a problem with your liver or pancreas.
Item
You have a problem with your liver or pancreas.
boolean
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)
C0030286 (UMLS CUI 2011AA)
3855007 (SNOMED CT 2011_0131)
10033616 (MedDRA 14.1)
K86.9 (ICD-10-CM Version 2010)
577.9 (ICD-9-CM Version 2011)
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
Item
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
Item
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
boolean
C0863135 (UMLS CUI 2011AA)
271230004 (SNOMED CT 2011_0131)
10040167 (MedDRA 14.1)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
Item
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0342190 (UMLS CUI 2011AA)
10070569 (MedDRA 14.1)
C0025268 (UMLS CUI 2011AA)
61808009 (SNOMED CT 2011_0131)
10028191 (MedDRA 14.1)
E31.22 (ICD-10-CM Version 2010)
258.02 (ICD-9-CM Version 2011)
C0025269 (UMLS CUI 2011AA)
61530001 (SNOMED CT 2011_0131)
10056420 (MedDRA 14.1)
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
Item
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
You have had an organ transplant except for corneal transplant.
Item
You have had an organ transplant except for corneal transplant.
boolean
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0010042 (UMLS CUI 2011AA)
60656008 (SNOMED CT 2011_0131)
10054846 (MedDRA 14.1)
11.60 (ICD-9-CM Version 2011)
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
Item
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
boolean
C0039798 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1704735 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
Item
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
boolean
C0021430 (UMLS CUI 2011AA)
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
Item
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
Item
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
boolean
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
You have previously participated or signed an informed consent document for this same type of study and study drug.
Item
You have previously participated or signed an informed consent document for this same type of study and study drug.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C2348583 (UMLS CUI 2011AA)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0035171 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
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