Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076088
• Other study ID #: 0431-121
• Secondary ID: 2010_514
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2010
• Last updated: April 27, 2015
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• has type 2 diabetes mellitus

• is male, a female who cannot have children, or a female who agrees to use birth control during the study

• is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

• Patient has type 1 diabetes mellitus or ketoacidosis

• Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)

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

• Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer

• Patient is HIV positive

• Patient is 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 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
• Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
• Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
• Placebo
Matching placebo tablets to sitagliptin or metformin for 24 weeks.
• Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 24	A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.	Baseline and Week 24	No
Secondary	Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24	Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.	Baseline and Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.	Baseline and Week 24	No