Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Sitagliptin, Insulin
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.
Interventions
DRUGSitagliptin
100 mg once daily for 6 months
DRUGGlimepiride
1 mg/2 mg/3 mg once daily
DRUGMetformin
\>=1000 mg twice daily
DRUGInsulin
TDD \> 10 IU once/twice daily
Sponsors
Jothydev's Diabetes and Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in total daily dose (TDD) of insulin | 6 months | Change from baseline in insulin TDD (30-day geometric mean) at Month 6 |
| 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 | — |
| 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 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) |
| Change in lipid profile from baseline | 6 months | — |
Countries
India
Outcome results
None listed