Eligibility Type 2 Diabetes Mellitus NCT00641407

1 moduli

StudyEvent: Eligibility
1. Eligibility Type 2 Diabetes Mellitus NCT00641407

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Type 2 Diabetes Mellitus NCT00641407