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

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: 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:

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

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


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076088

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.


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 )
Study First Received:	February 24, 2010
Results First Received:	December 17, 2013
Last Updated:	April 27, 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

ClinicalTrials.gov processed this record on July 14, 2017