ID

29113

Description

Pioglitazone Incretin Study; ODM derived from: https://clinicaltrials.gov/show/NCT00656864

Link

https://clinicaltrials.gov/show/NCT00656864

Keywords

Versions (1)
  1. 2/26/18 2/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00656864

English

Eligibility Diabetes Mellitus, Type 2 NCT00656864

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes controlled with diet+exercise or metformin monotherapy
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4]
C0025598
hba1c less than or equal to 7%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
women will be non-fertile or practicing birth control
Description

Gender Fertility Absent | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute or chronic medical conditions that would contraindicate participation
Description

Medical condition Study Subject Participation Status Contraindicated | Chronic disease Study Subject Participation Status Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444657
class iii or iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients taking antidiabetic medications other than metformin, oral or chronic topical steroids, weight loss agents, antipsychotics, or other drugs that could affect insulin sensitivity or secretion.
Description

Antidiabetics | Exception Metformin | Topical steroids Oral | Topical steroids chronic | Weight-Loss Agents | Antipsychotic Agents | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Affecting Insulin secretion

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C2064827
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C2064827
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0376606
UMLS CUI [6]
C0040615
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0920563
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C1256369
ast or alt more than 2.5 times the upper limit of normal
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
active alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
weight greater than 300 pounds
Description

Body Weight Pounds Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
UMLS CUI [1,3]
C1265611
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00656864

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin
Item
type 2 diabetes controlled with diet+exercise or metformin monotherapy
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Glucohemoglobin measurement
Item
hba1c less than or equal to 7%
boolean
C0202054 (UMLS CUI [1])
Gender Fertility Absent | Gender Contraceptive methods
Item
women will be non-fertile or practicing birth control
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Study Subject Participation Status Contraindicated | Chronic disease Study Subject Participation Status Contraindicated
Item
acute or chronic medical conditions that would contraindicate participation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
Heart failure New York Heart Association Classification
Item
class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antidiabetics | Exception Metformin | Topical steroids Oral | Topical steroids chronic | Weight-Loss Agents | Antipsychotic Agents | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Affecting Insulin secretion
Item
patients taking antidiabetic medications other than metformin, oral or chronic topical steroids, weight loss agents, antipsychotics, or other drugs that could affect insulin sensitivity or secretion.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C2064827 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C2064827 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0376606 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0920563 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C1256369 (UMLS CUI [8,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast or alt more than 2.5 times the upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Substance Use Disorders
Item
active alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Body Weight Pounds Quantity
Item
weight greater than 300 pounds
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
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