A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00813995

Purpose

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Comparator: sitagliptin phosphate Drug: Comparator: Placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the effect of the addition of sitagliptin compared with placebo on HbA1c. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the effect of the addition of sitagliptin compared with placebo on 2 hour post meal glucose and fasting plasma glucose. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental sitagliptin phosphate	Drug: Comparator: sitagliptin phosphate All patients will receive placebo tablets two weeks prior to treatment period. Patients will receive Sitagliptin phosphate 100 mg tablets q.d. and continue on stable dose of metformin therapy. Treatment period of 24 weeks.
2: Placebo Comparator Placebo	Drug: Comparator: Placebo All patients will receive placebo tablets two weeks prior to treatment period. Patients will receive placebo Sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy. Treatment period of 24 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

18 - 78 years of age
Currently on metformin monotherapy

Exclusion Criteria:

History of Type 1 diabetes mellitus or ketoacidosis
Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
Have undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
Currently participating in a study or have participated in a study with or without an investigational compound or device within the past 12 weeks
History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
HIV positive
Pregnant, breast-feeding or planning to become pregnant during the study
User of recreational or illicit drugs or have a recent history (within the past year) of drug or alcohol abuse or dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813995

Locations

China
Merck Sharp & Dohme (China) Ltd.	Recruiting
Beijing, China, 100738
Contact: Jane Lin 86-21-6391-5522

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_601, MK0431-074
Study First Received:	December 19, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00813995
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009