ID

21764

Description

Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.; ODM derived from: https://clinicaltrials.gov/show/NCT00770952

Link

https://clinicaltrials.gov/show/NCT00770952

Keywords

Versions (1)
  1. 4/29/17 4/29/17 -
Uploaded on

April 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00770952

English

Eligibility Diabetes Mellitus NCT00770952

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes according to the american diabetes association criteria.
Description

diabetes mellitus type 2

Data type

boolean

Alias
UMLS CUI [1]
C0011860
treatment with glimepiride monotherapy (1-3 mg per day) 3 months before entering the study.
Description

glimepiride

Data type

boolean

Alias
UMLS CUI [1]
C0061323
glycosylated hemoglobin greater than 6.5%, but less than 8.5% and/ or fasting plasma glucose greater than 7 mmol/l within the last 4 weeks.
Description

HbA1c, fasting plasma glucose

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2]
C0583513
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
Description

pregnancy, breast feeding, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus.
Description

diabetes mellitus type 1

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
Description

drug hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0013182
progressive fatal disease.
Description

progressive fatal diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C1335499
history of drug or alcohol abuse during the last 5 years.
Description

drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
more than one unexplained episode of severe hypoglycemia within 6 months prior to entering the study.
Description

severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
a history of significant cardiovascular (new york heart association stage i - iv), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.8 mg/dl; glomerular filtration rate less than 40 ml/min as estimated by the cockroft-gault formula), neurological, psychiatric and/or hematological disease, history of macular edema.
Description

cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric or hematological disease, macular edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0017178
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0201836
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0201976
UMLS CUI [5,3]
C0017654
UMLS CUI [5,4]
C4064204
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0018939
UMLS CUI [9]
C0271051
blood donation within the last 30 days.
Description

blood donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Description

medication or herbal treatment interfere with drug evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1360419
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0013175
cyp2c9 inductors
Description

cyp2c9 inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850046
cyp2c9 inhibitors
Description

cyp2c9 inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3850060
rifampicin
Description

rifampicin

Data type

boolean

Alias
UMLS CUI [1]
C0035608
fluconazole
Description

fluconazole

Data type

boolean

Alias
UMLS CUI [1]
C0016277
drugs used for treating type 2 diabetes (insulin, insulin analogous compounds and oral antidiabetic drugs)
Description

diabetes mellitus type 2 drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0013227
pretreatment with thiazolidinediones within the last 12 months.
Description

thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
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Similar models

Eligibility Diabetes Mellitus NCT00770952

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus type 2
Item
type 2 diabetes according to the american diabetes association criteria.
boolean
C0011860 (UMLS CUI [1])
glimepiride
Item
treatment with glimepiride monotherapy (1-3 mg per day) 3 months before entering the study.
boolean
C0061323 (UMLS CUI [1])
HbA1c, fasting plasma glucose
Item
glycosylated hemoglobin greater than 6.5%, but less than 8.5% and/ or fasting plasma glucose greater than 7 mmol/l within the last 4 weeks.
boolean
C0019018 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
pregnancy, breast feeding, contraception
Item
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
diabetes mellitus type 1
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
drug hypersensitivity
Item
history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
boolean
C0013182 (UMLS CUI [1])
progressive fatal diseases
Item
progressive fatal disease.
boolean
C0205082 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
drug or alcohol abuse
Item
history of drug or alcohol abuse during the last 5 years.
boolean
C0038586 (UMLS CUI [1])
severe hypoglycemia
Item
more than one unexplained episode of severe hypoglycemia within 6 months prior to entering the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric or hematological disease, macular edema
Item
a history of significant cardiovascular (new york heart association stage i - iv), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.8 mg/dl; glomerular filtration rate less than 40 ml/min as estimated by the cockroft-gault formula), neurological, psychiatric and/or hematological disease, history of macular edema.
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0201836 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0201976 (UMLS CUI [5,2])
C0017654 (UMLS CUI [5,3])
C4064204 (UMLS CUI [5,4])
C0027765 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0271051 (UMLS CUI [9])
blood donation
Item
blood donation within the last 30 days.
boolean
C0005794 (UMLS CUI [1])
medication or herbal treatment interfere with drug evaluation
Item
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0013227 (UMLS CUI [1,1])
C1360419 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0013175 (UMLS CUI [1,4])
cyp2c9 inducers
Item
cyp2c9 inductors
boolean
C3850046 (UMLS CUI [1])
cyp2c9 inhibitors
Item
cyp2c9 inhibitors
boolean
C3850060 (UMLS CUI [1])
rifampicin
Item
rifampicin
boolean
C0035608 (UMLS CUI [1])
fluconazole
Item
fluconazole
boolean
C0016277 (UMLS CUI [1])
diabetes mellitus type 2 drugs
Item
drugs used for treating type 2 diabetes (insulin, insulin analogous compounds and oral antidiabetic drugs)
boolean
C0011860 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
thiazolidinediones
Item
pretreatment with thiazolidinediones within the last 12 months.
boolean
C1257987 (UMLS CUI [1])
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