ID

42140

Description

ODM derived from http://clinicaltrials.gov/show/NCT01408095

Link

http://clinicaltrials.gov/show/NCT01408095

Keywords

Versions (4)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01408095 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
Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
Description

Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*1
C0011860
May be treated with:
Description

May be treated with:

Data type

boolean

Alias
UMLS CUI 2011AA
CL415205
UMLS CUI 2011AA
C0332293
SNOMED CT 2011_0131
28995006
1. Diet and exercise alone or
Description

1. Diet and exercise alone or

Data type

boolean

Alias
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
C0205171
SNOMED CT 2011_0131
50607009
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
Description

2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or

Data type

boolean

Alias
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
C1947911
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
Description

3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or

Data type

boolean

Alias
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
C1947911
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C1579432
UMLS CUI 2011AA
C0246689
SNOMED CT 2011_0131
386964000
LOINC Version 232
MTHU017515
UMLS CUI 2011AA
C1323198
SNOMED CT 2011_0131
387070004
LOINC Version 232
MTHU026435
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
Description

4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years

Data type

boolean

Alias
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
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1579432
Must have an Hemoglobin A1c value between 7% and 10%
Description

Must have an Hemoglobin A1c value between 7% and 10%

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

Must have a body mass index (BMI) between 20 and 40 kg/m2

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
Description

Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
If female, you must not be able to get pregnant
Description

If female, you must not be able to get pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
Description

Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction

Data type

boolean

Alias
UMLS CUI 2011AA
C0026605
SNOMED CT 2011_0131
363882003
UMLS CUI 2011AA
C2698977
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
UMLS CUI 2011AA
C0302828
Exclusion Criteria
Description

Exclusion Criteria

Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Description

Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months 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
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C1579432
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Description

Have a gastrointestinal disease that significantly impacts 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
C1261985
MedDRA 14.1
10060785
UMLS CUI 2011AA
C0038895
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Description

Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months

Data type

boolean

Alias
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
C0853088
MedDRA 14.1
10020997
UMLS CUI 2011AA
C1546435
HL7 V3 2006_05
ER
UMLS CUI 2011AA
C1554196
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
C0858269
MedDRA 14.1
10024858
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Description

Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C0013231
SNOMED CT 2011_0131
329505003, 80288002
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
Description

Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
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
C0205434
SNOMED CT 2011_0131
5650002
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
Description

Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020540
SNOMED CT 2011_0131
70272006
MedDRA 14.1
10025600
UMLS CUI 2011AA
C0035067
SNOMED CT 2011_0131
302233006
MedDRA 14.1
10038378
UMLS CUI 2011AA
C0428895
SNOMED CT 2011_0131
251080003
MedDRA 14.1
10023533
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
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
Description

Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope

Data type

boolean

Alias
UMLS CUI 2011AA
C1882512
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
C0039070
SNOMED CT 2011_0131
272030005
MedDRA 14.1
10042772
LOINC Version 232
MTHU020851
ICD-10-CM Version 2010
R55
ICD-9-CM Version 2011
780.2
CTCAE 1105E
E12832
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0681841
LOINC Version 232
MTHU013812
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
Description

Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests

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
C0267797
SNOMED CT 2011_0131
37871000
MedDRA 14.1
10019727
ICD-10-CM Version 2010
B17.9
UMLS CUI 2011AA
C0019189
SNOMED CT 2011_0131
76783007
MedDRA 14.1
10008909
ICD-10-CM Version 2010
K73.9
ICD-9-CM Version 2011
571.40
UMLS CUI 2011AA
C0877359
MedDRA 14.1
10048557
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
Description

Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0917873
SNOMED CT 2011_0131
265764009
MedDRA 14.1
10049051
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1441506
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0039798
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Description

Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C1976106
LOINC Version 232
MTHU026462
UMLS CUI 2011AA
C0020557
SNOMED CT 2011_0131
302870006
MedDRA 14.1
10020869
CTCAE 1105E
E12299
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0003367
SNOMED CT 2011_0131
57952007
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
Description

Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0744425
MedDRA 14.1
10071104
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0360289
SNOMED CT 2011_0131
350088003
UMLS CUI 2011AA
C0556393
SNOMED CT 2011_0131
228376009
Have an active or untreated malignancy or have been 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 < 5 years
Description

Have an active or untreated malignancy or have been 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 < 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1518422
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 history of seizure disorder
Description

Have a history of seizure disorder

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009, 313307000
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
Description

Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1283828
SNOMED CT 2011_0131
363703001
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2962753
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
Description

Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332324
SNOMED CT 2011_0131
83185005
UMLS CUI 2011AA
C0178623
UMLS CUI 2011AA
C1142644
SNOMED CT 2011_0131
422741004
UMLS CUI 2011AA
C1706062
UMLS CUI 2011AA
CL407604
UMLS CUI 2011AA
C0678793
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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)
Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
Item
Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
boolean
C0011900 (UMLS CUI 1)
C0011860 (UMLS CUI 1*1)
May be treated with:
Item
May be treated with:
boolean
CL415205 (UMLS CUI 2011AA)
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
1. Diet and exercise alone or
Item
1. Diet and exercise alone or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
Item
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C1947911 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
Item
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C1947911 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0038766 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
C0246689 (UMLS CUI 2011AA)
386964000 (SNOMED CT 2011_0131)
MTHU017515 (LOINC Version 232)
C1323198 (UMLS CUI 2011AA)
387070004 (SNOMED CT 2011_0131)
MTHU026435 (LOINC Version 232)
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
Item
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C1947911 (UMLS CUI 2011AA)
C0038766 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
Must have an Hemoglobin A1c value between 7% and 10%
Item
Must have an Hemoglobin A1c value between 7% and 10%
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Must have a body mass index (BMI) between 20 and 40 kg/m2
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
Item
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
boolean
C0005910 (UMLS CUI 2011AA)
If female, you must not be able to get pregnant
Item
If female, you must not be able to get pregnant
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
Item
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
boolean
C0026605 (UMLS CUI 2011AA)
363882003 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0302828 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Item
Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
boolean
C0240016 (UMLS CUI 2011AA)
246491008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0038766 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Item
Have a gastrointestinal disease that significantly impacts 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)
C1261985 (UMLS CUI 2011AA)
10060785 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Item
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
boolean
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)
C0853088 (UMLS CUI 2011AA)
10020997 (MedDRA 14.1)
C1546435 (UMLS CUI 2011AA)
ER (HL7 V3 2006_05)
C1554196 (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)
C0858269 (UMLS CUI 2011AA)
10024858 (MedDRA 14.1)
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Item
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
boolean
C1512806 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
Item
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
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)
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
Item
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020540 (UMLS CUI 2011AA)
70272006 (SNOMED CT 2011_0131)
10025600 (MedDRA 14.1)
C0035067 (UMLS CUI 2011AA)
302233006 (SNOMED CT 2011_0131)
10038378 (MedDRA 14.1)
C0428895 (UMLS CUI 2011AA)
251080003 (SNOMED CT 2011_0131)
10023533 (MedDRA 14.1)
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)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
Item
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
boolean
C1882512 (UMLS CUI 2011AA)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0039070 (UMLS CUI 2011AA)
272030005 (SNOMED CT 2011_0131)
10042772 (MedDRA 14.1)
MTHU020851 (LOINC Version 232)
R55 (ICD-10-CM Version 2010)
780.2 (ICD-9-CM Version 2011)
E12832 (CTCAE 1105E)
C1705492 (UMLS CUI 2011AA)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
Item
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
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)
C0267797 (UMLS CUI 2011AA)
37871000 (SNOMED CT 2011_0131)
10019727 (MedDRA 14.1)
B17.9 (ICD-10-CM Version 2010)
C0019189 (UMLS CUI 2011AA)
76783007 (SNOMED CT 2011_0131)
10008909 (MedDRA 14.1)
K73.9 (ICD-10-CM Version 2010)
571.40 (ICD-9-CM Version 2011)
C0877359 (UMLS CUI 2011AA)
10048557 (MedDRA 14.1)
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
Item
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
boolean
C1514756 (UMLS CUI 2011AA)
C0917873 (UMLS CUI 2011AA)
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1441506 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Item
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
boolean
C1976106 (UMLS CUI 2011AA)
MTHU026462 (LOINC Version 232)
C0020557 (UMLS CUI 2011AA)
302870006 (SNOMED CT 2011_0131)
10020869 (MedDRA 14.1)
E12299 (CTCAE 1105E)
C1409616 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0003367 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
Item
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
boolean
C1514756 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0744425 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0556393 (UMLS CUI 2011AA)
228376009 (SNOMED CT 2011_0131)
Have an active or untreated malignancy or have been 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 < 5 years
Item
Have an active or untreated malignancy or have been 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 < 5 years
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
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 history of seizure disorder
Item
Have a history of seizure disorder
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
Item
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1283828 (UMLS CUI 2011AA)
363703001 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2962753 (UMLS CUI 2011AA)
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
Item
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
boolean
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0332324 (UMLS CUI 2011AA)
83185005 (SNOMED CT 2011_0131)
C0178623 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C1706062 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0678793 (UMLS CUI 2011AA)
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