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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341717
• Other study ID #: JDC/SITA/021/2011
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2011
• Last updated: May 29, 2014
• Start date: February 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Jothydev's Diabetes and Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Sitagliptin
100 mg once daily for 6 months
• Glimepiride
1 mg/2 mg/3 mg once daily
• Metformin
>=1000 mg twice daily
• Insulin
TDD > 10 IU once/twice daily

Locations

Country	Name	City	State
India	Jothydev's Diabetes and Research Center	Thiruvananthapuram	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jothydev's Diabetes and Research Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	six months	No
Secondary	Change in total daily dose (TDD) of insulin	Change from baseline in insulin TDD (30-day geometric mean) at Month 6	6 months	No
Secondary	Episodes of hypoglycemia	Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available	6 months	Yes
Secondary	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)	6 months	No
Secondary	change in weight and BMI		6 months	No
Secondary	Change in both HbA1c and TDD	Proportion of patients achieving both HbA1c =6.5% AND reduction in TDD (total daily dose of insulin)	6 months	No
Secondary	Change in insulin resistance and beta cell function	Change from baseline in c-peptide levels, homeostasis model assessments of ß-cell function and insulin resistance (HOMA-ß and HOMA-IR)	6 months	No
Secondary	Change in lipid profile from baseline		6 months	No

External Links

•   About Diabetes Mellitus