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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076088
First Posted: February 25, 2010
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin 50 mg Drug: Metformin 500 mg Drug: Sitagliptin 100 mg Drug: Placebo Drug: Metformin 850 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 744
Actual Study Start Date: November 15, 2010
Study Completion Date: December 24, 2012
Primary Completion Date: December 24, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin 50 mg + metformin 500 mg
Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.
Drug: Sitagliptin 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®
Drug: Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Experimental: Sitagliptin 50 mg + metformin 850 mg
Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
Drug: Sitagliptin 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®
Drug: Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Active Comparator: Metformin 500 mg
Metformin 500 mg twice daily for 24 weeks.
Drug: Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Active Comparator: Metformin 850 mg
Metformin 850 mg twice daily for 24 weeks.
Drug: Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Experimental: Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
Drug: Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
Other Name: Januvia®, Tesavel®, Xelevia®, Ristaben®
Placebo Comparator: Placebo
Matching placebo tablets for 24 weeks.
Drug: Placebo
Matching placebo tablets to sitagliptin or metformin for 24 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076088


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01076088     History of Changes
Other Study ID Numbers: 0431-121
2010_514 ( Other Identifier: Merck Registration Number )
First Submitted: February 24, 2010
First Posted: February 25, 2010
Results First Submitted: December 17, 2013
Results First Posted: February 6, 2014
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action