ID

29135

Description

Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00690456

Lien

https://clinicaltrials.gov/show/NCT00690456

Mots-clés

Versions (1)
  1. 27/02/2018 27/02/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 février 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00690456

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT00690456

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
hba1c between 7% to 10% at screening visit
Description

Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202054
treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
Description

Metformin Dose Stable U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
Description

LIPID MODIFYING AGENTS Change | CORTICOSTEROIDS FOR SYSTEMIC USE | Anti-Obesity Agents | Weight-Loss Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C3653535
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0376607
UMLS CUI [4]
C0376606
weight loss of more than 5 kg within 3 months prior to screening
Description

Weight decreased Quantity Time period

Type de données

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1948053
administration of other investigational drugs within 30 days prior to screening visit
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
prior exposure to cb1 antagonists including rimonabant
Description

Exposure to Cannabinoid Receptor Antagonists | Exposure to rimonabant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2927149
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1142933
presence or history of cancer within the past five years
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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 | Severe Mental Disorders compromise Study Subject Participation Status | Mental disorders Serious Uncontrolled | Major Depressive Disorder

Type de données

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]
C4046029
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C1269683
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

Type de données

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 NCT00690456

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
history of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c between 7% to 10% at screening visit
boolean
C0202054 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
LIPID MODIFYING AGENTS Change | CORTICOSTEROIDS FOR SYSTEMIC USE | Anti-Obesity Agents | Weight-Loss Agents
Item
within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
boolean
C3653535 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
C0376606 (UMLS CUI [4])
Weight decreased Quantity Time period
Item
weight loss of more than 5 kg within 3 months prior to screening
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Investigational New Drugs
Item
administration of other investigational drugs within 30 days prior to screening visit
boolean
C0013230 (UMLS CUI [1])
Exposure to Cannabinoid Receptor Antagonists | Exposure to rimonabant
Item
prior exposure to cb1 antagonists including rimonabant
boolean
C0332157 (UMLS CUI [1,1])
C2927149 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1142933 (UMLS CUI [2,2])
Malignant Neoplasms
Item
presence or history of cancer within the past five years
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorders compromise Study Subject Participation Status | Mental disorders Serious Uncontrolled | Major Depressive Disorder
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])
C4046029 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C1269683 (UMLS CUI [4])
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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