Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02585505
Eligibility Criteria:
Inclusion Criteria:
* • Patients with type 2 diabetes mellitus between 30 and 65 years of age.
* Duration of diabetes ≥ 5 years.
* Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.
* Requiring insulin therapy for last six month
* On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.
* GAD antibody negative status.
Exclusion Criteria:
* Patients with type 1 diabetes mellitus or secondary diabetes
* Patients with serum creatinine \> 1.5 mg/dL
* Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
* History of cholecystitis/ cholelithiasis/ cholecystectomy.
* Seropositivity for HIV, HBsAg and HCV.
* History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT02585505
Study Brief:
Protocol Section:
NCT02585505