Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01341717
- Lead Sponsor
- Jothydev's Diabetes and Research Centre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin along with metformin and insulin Insulin - Glimepiride as an active comparator to Sitagliptin Insulin - Sitagliptin along with metformin and insulin Sitagliptin - Sitagliptin along with metformin and insulin Glimepiride - Sitagliptin along with metformin and insulin Metformin - Glimepiride as an active comparator to Sitagliptin Glimepiride - Glimepiride as an active comparator to Sitagliptin Sitagliptin - Glimepiride as an active comparator to Sitagliptin Metformin -
- Primary Outcome Measures
Name Time Method Reduction in HbA1c from baseline six months 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%.
- Secondary Outcome Measures
Name Time Method Change in both HbA1c and TDD 6 months Proportion of patients achieving both HbA1c ≤6.5% AND reduction in TDD (total daily dose of insulin)
Change in lipid profile from baseline 6 months Change in total daily dose (TDD) of insulin 6 months Change from baseline in insulin TDD (30-day geometric mean) at Month 6
Change in insulin resistance and beta cell function 6 months Change from baseline in c-peptide levels, homeostasis model assessments of β-cell function and insulin resistance (HOMA-β and HOMA-IR)
Episodes of hypoglycemia 6 months Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available
Proportion of patients with HbA1c reduction 6 months Proportion of patients, who completed treatment , with HbA1c value \<6.5% \& ≤7.3% at end of study (Month 6)
change in weight and BMI 6 months
Trial Locations
- Locations (1)
Jothydev's Diabetes and Research Center
🇮🇳Thiruvananthapuram, Kerala, India