Clinical trial NCT01341717: Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Sitagliptin
Insulin
Lead sponsor: Jothydev's Diabetes and Research Centre
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 440
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Reduction in HbA1c from baseline
timeFrame: six months
Secondary outcomes:
measure: Change in total daily dose (TDD) of insulin
timeFrame: 6 months
measure: Episodes of hypoglycemia
timeFrame: 6 months
measure: Proportion of patients with HbA1c reduction
timeFrame: 6 months
measure: change in weight and BMI
timeFrame: 6 months
measure: Change in both HbA1c and TDD
timeFrame: 6 months
measure: Change in insulin resistance and beta cell function
timeFrame: 6 months
measure: Change in lipid profile from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Thiruvananthapuram
country: India
facility: Jothydev's Diabetes and Research Center
state: Kerala
Study officials:
affiliation: Jothydev's Diabetes and Research Center
name: Jothydev Kesavadev, MD
role: PRINCIPAL_INVESTIGATOR
References: