Information:
Error:
ID
20690
Description
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as Add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00396227
Link
https://clinicaltrials.gov/show/NCT00396227
Keywords
Versions (1)
- 3/11/17 3/11/17 -
Uploaded on
March 11, 2017
DOI
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License
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00396227
Eligibility Diabetes Mellitus, Type 2 NCT00396227
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00396227
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Metformin Dose Stable U/day
Item
patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to visit 1 (week-2)
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Metformin Dose Maintenance
Item
agreement to maintain the same dose of metformin from screening to the end of the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Age
Item
age in the range of 18-80 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) in the range of 22-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 7.0 to 10%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fpg <270 mg/dl (15 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Liver disease
Item
liver disease
boolean
C0023895 (UMLS CUI [1])
Insulin | Antidiabetics Oral | Metformin
Item
treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to visit 1
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])