Effects Of Sitagliptin On T2DM Patients On Treatment With Metformin And Insuli
Phase 4
- Conditions
- Health Condition 1: null- Healthy type 2 diabetes patients
- Registration Number
- CTRI/2012/08/002926
- Lead Sponsor
- Jothydevs Diabetes and Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 440
Inclusion Criteria
•T2DM patients on metformin and biphasic or basal regimens of insulin
•HbA1c >=7.3% to <=8.5%
•Age: 25 to 60 yrs
•Insulin TDD > 10 IU
Exclusion Criteria
•History of type 1 diabetes mellitus
•History of pancreatitis
•Creatinine clearance <=50 mL/min
•Chronic liver & kidney diseases, SGOT/PT>=2.5x upper limit of normal, uncontrolled thyroid disorders, cardiac failure, hemochromatosis, autoimmune disorders, and corticosteroid intake.
•BMI >40 kg/m2
•Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method