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ID
38765
Description
A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01691755
Link
https://clinicaltrials.gov/show/NCT01691755
Keywords
Versions (2)
- 11/2/19 11/2/19 -
- 11/2/19 11/2/19 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
November 2, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Diabetes Mellitus, Type 2 NCT01691755
Eligibility Diabetes Mellitus, Type 2 NCT01691755
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01691755
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Hypoglycemic Agents Absent
Item
patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose </=240 mg/dl at pre-randomization visit
boolean
C0583513 (UMLS CUI [1])
Diet therapy Maintenance | Exercise Habits Maintenance
Item
agreement to maintain diet and exercise habits during the study
boolean
C0012159 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0018464 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
C0024501 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0018464 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus Due to Injury of pancreas | Complications of Diabetes Mellitus Metabolic
Item
patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0273163 (UMLS CUI [2,3])
C0342257 (UMLS CUI [3,1])
C0311400 (UMLS CUI [3,2])
C0271640 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0273163 (UMLS CUI [2,3])
C0342257 (UMLS CUI [3,1])
C0311400 (UMLS CUI [3,2])
Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Agonist Dual
Item
any previous treatment with thiazolidinedione or a dual ppar agonist
boolean
C1257987 (UMLS CUI [1])
C0166418 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0166418 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Weight reduction regimen | Lipoprotein modification Therapy | Exception Statins Dose Stable
Item
any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
boolean
C0311130 (UMLS CUI [1])
C1158918 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C1158918 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Symptomatic congestive heart failure New York Heart Association Classification
Item
symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,2])