Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jothydev's Diabetes and Research Centre
• Treatments: Glimepiride; Insulin; Insulin, Globin Zinc; Metformin; Sitagliptin Phosphate

Criteria

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:

• Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase

• History of type 1 diabetes mellitus

• 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, corticosteroid intake.

• BMI >40 kg/m2