ID

32737

Description

Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00641407

Link

https://clinicaltrials.gov/show/NCT00641407

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00641407

English

Eligibility Type 2 Diabetes Mellitus NCT00641407

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 30-70 years, with a duration of known diabetes > 2 years
Description

Age | Diabetes Mellitus Duration

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0449238
and treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
Description

Oral hypoglycemic Quantity | Metformin Dose Stable | Sulfonylureas Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
body mass index less than 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c level between 7.5 and 10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
and fasting plasma glucose of 120 mg/dl or greater.
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria included pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous use of insulin or other antihyperglycemic drugs
Description

Insulin | Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0020616
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
Description

Disease Somatic | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986476
UMLS CUI [2]
C0004936
to minimize the likelihood of including subjects with late-onset type 1 diabetes
Description

Diabetes mellitus, insulin-dependent, late onset

Data type

boolean

Alias
UMLS CUI [1]
C1865291
candidate with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.25 pmol/ml were excluded
Description

Anti-GAD antibody positive | Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C1167896
UMLS CUI [2]
C2208720
also excluded were patients with abnormal safety laboratory tests
Description

Safety Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C0438215
including liver enzymes (alt, ast, afos) higher than three times the upper limit of normal and serum creatinine > 1.4 mg/dl)
Description

Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0235996
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
UMLS CUI [5]
C0201976
history of drug abuse
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
poor compliance with the 8-point daily glucose profile measurement
Description

Poor compliance Glucose measurement Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C0332173
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00641407

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus Duration
Item
men and women aged 30-70 years, with a duration of known diabetes > 2 years
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Oral hypoglycemic Quantity | Metformin Dose Stable | Sulfonylureas Dose Stable
Item
and treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Body mass index
Item
body mass index less than 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c level between 7.5 and 10%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
and fasting plasma glucose of 120 mg/dl or greater.
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
exclusion criteria included pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Insulin | Hypoglycemic Agents
Item
previous use of insulin or other antihyperglycemic drugs
boolean
C0021641 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
Investigational New Drugs
Item
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
Item
presence of any clinically relevant somatic or mental diseases
boolean
C0012634 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
Diabetes mellitus, insulin-dependent, late onset
Item
to minimize the likelihood of including subjects with late-onset type 1 diabetes
boolean
C1865291 (UMLS CUI [1])
Anti-GAD antibody positive | Fasting C-peptide level
Item
candidate with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.25 pmol/ml were excluded
boolean
C1167896 (UMLS CUI [1])
C2208720 (UMLS CUI [2])
Safety Laboratory test result abnormal
Item
also excluded were patients with abnormal safety laboratory tests
boolean
C0036043 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum
Item
including liver enzymes (alt, ast, afos) higher than three times the upper limit of normal and serum creatinine > 1.4 mg/dl)
boolean
C0235996 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Drug abuse
Item
history of drug abuse
boolean
C0013146 (UMLS CUI [1])
Poor compliance Glucose measurement Daily
Item
poor compliance with the 8-point daily glucose profile measurement
boolean
C0032646 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
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