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

Jothydev's Diabetes and Research Centre440 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

440

Conditions

Diabetes Mellitus, Type 2

Interventions

SitagliptinDRUG

100 mg once daily for 6 months

GlimepirideDRUG

1 mg/2 mg/3 mg once daily

MetforminDRUG

\>=1000 mg twice daily

Insulin

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Jothydev's Diabetes and Research Center

Thiruvananthapuram, Kerala, India

Outcomes

Primary Outcomes

Reduction in HbA1c from baseline

To confirm the efficacy of metformin+ insulin+ sitagliptin in controlling glycemia with respect to change from baseline in HbA1c after 24 weeks of administration. This will be accomplished by comparing the difference in change from baseline in HbA1c after 24 weeks of administration, compared with metformin+insulin+glimepiride to a non-inferiority limit of 0.3% , and if non-inferiority is proven, to a superiority limit of 0%.

Time frame: six months

Secondary Outcomes

Change in total daily dose (TDD) of insulin

Change from baseline in insulin TDD (30-day geometric mean) at Month 6

Time frame: 6 months

Episodes of hypoglycemia

Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available

Time frame: 6 months

Proportion of patients with HbA1c reduction

Proportion of patients, who completed treatment , with HbA1c value \<6.5% \& ≤7.3% at end of study (Month 6)

Time frame: 6 months

change in weight and BMI

Time frame: 6 months

Change in both HbA1c and TDD

Proportion of patients achieving both HbA1c ≤6.5% AND reduction in TDD (total daily dose of insulin)

Time frame: 6 months

Change in insulin resistance and beta cell function

Change from baseline in c-peptide levels, homeostasis model assessments of β-cell function and insulin resistance (HOMA-β and HOMA-IR)

Data from ClinicalTrials.gov

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