ID

29145

Description

Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00754689

Link

https://clinicaltrials.gov/show/NCT00754689

Keywords

Versions (1)
  1. 3/1/18 3/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 1, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00754689

English

Eligibility Diabetes Mellitus, Type 2 NCT00754689

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ada criteria)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline a1c assessment in all patients
Description

Oral hypoglycemic Absent | Hypoglycemic Agents Injectable Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0086466
UMLS CUI [2,3]
C0332197
a1c ≥7.0 % and ≤10.0 %
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
fasted plasma glucose at screening visit ≤260 mg/dl (14.44 mmol/l)
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
Description

Antidiabetics Oral | Antidiabetics Injectables

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0086466
in the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
Description

Anti-Obesity Agents | Weight-Loss Agents | CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2]
C0376606
UMLS CUI [3]
C3653708
presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
Description

Medical condition Severe compromises Study Subject Participation Status | Mental problem Severe compromises Study Subject Participation Status | Mental disorders Serious Uncontrolled | Major Depressive Disorder | Mental disorders Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0848067
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C1269683
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205082
presence or history of cancer within the past five years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status Aspect Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00754689

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
history of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ada criteria)
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic Absent | Hypoglycemic Agents Injectable Absent
Item
patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline a1c assessment in all patients
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
a1c ≥7.0 % and ≤10.0 %
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasted plasma glucose at screening visit ≤260 mg/dl (14.44 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Antidiabetics Injectables
Item
treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
Anti-Obesity Agents | Weight-Loss Agents | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
in the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
boolean
C0376607 (UMLS CUI [1])
C0376606 (UMLS CUI [2])
C3653708 (UMLS CUI [3])
Medical condition Severe compromises Study Subject Participation Status | Mental problem Severe compromises Study Subject Participation Status | Mental disorders Serious Uncontrolled | Major Depressive Disorder | Mental disorders Severe
Item
presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0848067 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C1269683 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Malignant Neoplasms
Item
presence or history of cancer within the past five years
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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