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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:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01076088
First received: February 24, 2010
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: sitagliptin phosphate (+) metformin hydrochloride
Drug: Comparator: metformin
Drug: Comparator: sitagliptin
Drug: Comparator: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in A1C at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 2-hour post meal glucose (2-h PMG) at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 744
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sitagliptin 50 mg + metformin 500 mg
 Drug: sitagliptin phosphate (+) metformin hydrochloride
Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks or sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
Experimental: 2
sitagliptin 50 mg + metformin 850 mg
 Drug: sitagliptin phosphate (+) metformin hydrochloride
Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks or sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
Active Comparator: 3
metformin 500 mg
 Drug: Comparator: metformin
Metformin 500 mg or 850 mg twice daily for 24 weeks.
Active Comparator: 4
metformin 850 mg
 Drug: Comparator: metformin
Metformin 500 mg or 850 mg twice daily for 24 weeks.
Experimental: 5
sitagliptin 100 mg
 Drug: Comparator: sitagliptin
Sitagliptin 100 mg once daily for 24 weeks.
Placebo Comparator: 6
placebo
 Drug: Comparator: Placebo
Placebo tablets for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is male, a female who cannot have children, or a female who agrees to use birth control during the study
  • Patient 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 combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

  • Patient has type 1 diabetes mellitus or ketoacidosis
  • Patient is taking a 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076088

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01076088     History of Changes
Other Study ID Numbers: 0431-121, 2010_514
Study First Received: February 24, 2010
Last Updated: January 11, 2013
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013