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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Sitagliptin 50 mg (Drug); Metformin 500 mg (Drug); Sitagliptin 100 mg (Drug); Placebo (Drug); Metformin 850 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

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

Primary outcome: Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Secondary outcome:

Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Eligibility

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2010
Last updated: April 27, 2015

Page last updated: August 23, 2015

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