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Completed

NCT Number: NCT01076088

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin 50 mg

Drug

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

Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®

metformin 500 mg

Drug

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

Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Sitagliptin 100 mg

Drug

Sitagliptin 100 mg once daily for 24 weeks.

Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®

Placebo

Drug

Matching placebo tablets to sitagliptin or metformin for 24 weeks.

Metformin 850 mg

Drug

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

Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (A1C) at Week 24

    Time frame: Baseline and Week 24

    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Secondary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Week 24

    Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2010
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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