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

NCT01076088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2017-05-23

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin 50 mg

Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.

DRUG

Metformin 500 mg

Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

DRUG

Sitagliptin 100 mg

Sitagliptin 100 mg once daily for 24 weeks.

DRUG

Placebo

Matching placebo tablets to sitagliptin or metformin for 24 weeks.

DRUG

Metformin 850 mg

Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-15
Primary Completion
2012-12-24
Completion
2012-12-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076088 on ClinicalTrials.gov