A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076075
• Other study ID #: 0431-229
• Secondary ID: 2010_513MK-0431-
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2010
• Last updated: January 21, 2016
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Hemoglobin A1C of =7.5% and =10.5%

• Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start

• Male, or a female who is highly unlikely to conceive

Exclusion Criteria:

• Type 1 diabetes mellitus or ketoacidosis

• Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start

• On a weight loss program not in the maintenance phase or on a weight loss medication

• History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer

• HIV positive

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin phosphate
Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
• Comparator: placebo to pioglitazone
Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
• Comparator: placebo to Sitagliptin
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
• Comparator: pioglitazone
Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
• Glimepiride or gliclazide
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
• Metformin
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of metformin; Phase B (Weeks 24- 54): stable dose, as prescribed by investigator, of metformin
• Pioglitazone rescue therapy
Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 dia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1C (%) at Week 24	Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.	Baseline and Week 24	No
Primary	Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54		Week 0 to Week 54	Yes
Primary	Number of Participants Discontinuing Study Drug Due to An Adverse Event		Week 0 to Week 54	Yes
Secondary	Change From Baseline in 2-hour Post-Meal Glucose at Week 24	Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.	Baseline and Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 24	Change from baseline reflects the Week 24 value minus the baseline value.	Baseline to Week 24	No