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 24Change 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
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