Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Open-labelled, Randomized, Active-controlled, Parallel-arm, Single-center Study on Effect of Sitagliptin on T2DM Patients on Treatment With Metformin and Insulin
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.
DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose
homoeostasis. DPP-4 inhibitors have been proved to promote glycemic control without
increasing risk of hypoglycemia and weight gain. In addition, they may improve beta-cell
function and do not have any known associations with overt cardiovascular or hepatic safety
risks.
Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/-
metformin has been shown to reduce HbA1c while being generally well-tolerated.
It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on
stable therapy with insulin & metformin. Apart from glycemic reduction, secondary effects
like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk
profile, etc. may be expected from addition of sitagliptin to treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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