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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Sitagliptin Drug: Glimepiride Drug: Metformin Drug: Insulin
Phase	Phase 4
Sponsor	Jothydev's Diabetes and Research Centre
Responsible Party	Jothydev's Diabetes and Research Centre
ClinicalTrials.gov Identifier	NCT01341717
First Received	April 23, 2011
Last Updated	November 8, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 23, 2011
Last Updated Date	November 8, 2013
Start Date	February 2012
Estimated Primary Completion Date	May 2014
Current Primary Outcome Measures	Reduction in HbA1c from baseline [Time Frame: six months] [Designated as safety issue: No]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%.
Current Secondary Outcome Measures	Change in total daily dose (TDD) of insulin [Time Frame: 6 months] [Designated as safety issue: No]Change from baseline in insulin TDD (30-day geometric mean) at Month 6 Episodes of hypoglycemia [Time Frame: 6 months] [Designated as safety issue: Yes]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 [Time Frame: 6 months] [Designated as safety issue: No]Proportion of patients, who completed treatment , with HbA1c value <6.5% & ≤7.3% at end of study (Month 6) change in weight and BMI [Time Frame: 6 months] [Designated as safety issue: No] Change in both HbA1c and TDD [Time Frame: 6 months] [Designated as safety issue: No]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 [Time Frame: 6 months] [Designated as safety issue: No]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 [Time Frame: 6 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Sitagliptin 100 mg once daily for 6 months Drug: Glimepiride 1 mg/2 mg/3 mg once daily Drug: Metformin >=1000 mg twice daily Drug: Insulin TDD > 10 IU once/twice daily
Study Arm (s)	Experimental: Sitagliptin along with metformin and insulin Active Comparator: Glimepiride as an active comparator to Sitagliptin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	440
Estimated Completion Date	May 2014
Estimated Primary Completion Date	May 2014
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
Gender	Both
Ages	25 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT01341717
Other Study ID Numbers	JDC/SITA/021/2011
Has Data Monitoring Committee	Yes
Information Provided By	Jothydev's Diabetes and Research Centre
Study Sponsor	Jothydev's Diabetes and Research Centre
Collaborators	Not Provided
Investigators	Principal Investigator: Jothydev Kesavadev, MD Jothydev's Diabetes and Research Center
Verification Date	November 2013

Locations[ + expand ][ + ]