ID

33086

Description

Pioglitazone Versus Metformin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00815399

Link

https://clinicaltrials.gov/show/NCT00815399

Keywords

Versions (1)
  1. 11/26/18 11/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00815399

English

Eligibility Type 2 Diabetes NCT00815399

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 30-75 years, with newly-diagnosed type 2 diabetes (according to the ada criteria) and never treated with antihyperglycemic drugs, were selected for the study. inclusion criteria also included a body mass index (bmi) >25 kg/m2, and hba1c level <10%.
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Absent | Body mass index | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0020616
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1305855
UMLS CUI [5]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any investigational drug within the previous 3 months
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
Description

Pharmaceutical Preparations Affecting Glycaemia control | Glucocorticoids, Systemic | Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3267174
UMLS CUI [2]
C3540777
UMLS CUI [3]
C0376606
presence of any clinically relevant somatic or mental diseases that anticipated poor adherence to diet regimens
Description

Disease Somatic | Mental disorders | Adherence Poor Diet therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986476
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2700379
UMLS CUI [3,3]
C0012159
to minimize the likelihood of including subjects with late-onset type 1 diabetes, candidates with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.76 ng/l (<0.25 pmol/l) were excluded
Description

Late onset Insulin-Dependent Diabetes Mellitus | Anti-GAD antibody positive | Plasma C-peptide level Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C4025592
UMLS CUI [1,2]
C0011854
UMLS CUI [2]
C1167896
UMLS CUI [3,1]
C1303121
UMLS CUI [3,2]
C0015663
also excluded were patients with abnormal laboratory tests, including liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) greater than 3 times the upper limit of normal, and serum creatinine greater than 123.8
Description

Laboratory test result abnormal | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0235996
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151849
UMLS CUI [6]
C0201976
μmol/l (1.4 mg/dl).
Description

ID.8

Data type

boolean

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Similar models

Eligibility Type 2 Diabetes NCT00815399

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Absent | Body mass index | Hemoglobin A1c measurement
Item
men and women aged 30-75 years, with newly-diagnosed type 2 diabetes (according to the ada criteria) and never treated with antihyperglycemic drugs, were selected for the study. inclusion criteria also included a body mass index (bmi) >25 kg/m2, and hba1c level <10%.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0020616 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1305855 (UMLS CUI [4])
C0474680 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
any investigational drug within the previous 3 months
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Glycaemia control | Glucocorticoids, Systemic | Weight-Loss Agents
Item
use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C3540777 (UMLS CUI [2])
C0376606 (UMLS CUI [3])
Disease Somatic | Mental disorders | Adherence Poor Diet therapy
Item
presence of any clinically relevant somatic or mental diseases that anticipated poor adherence to diet regimens
boolean
C0012634 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
C1510802 (UMLS CUI [3,1])
C2700379 (UMLS CUI [3,2])
C0012159 (UMLS CUI [3,3])
Late onset Insulin-Dependent Diabetes Mellitus | Anti-GAD antibody positive | Plasma C-peptide level Fasting
Item
to minimize the likelihood of including subjects with late-onset type 1 diabetes, candidates with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.76 ng/l (<0.25 pmol/l) were excluded
boolean
C4025592 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C1167896 (UMLS CUI [2])
C1303121 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
Laboratory test result abnormal | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum
Item
also excluded were patients with abnormal laboratory tests, including liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) greater than 3 times the upper limit of normal, and serum creatinine greater than 123.8
boolean
C0438215 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
ID.8
Item
μmol/l (1.4 mg/dl).
boolean
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