Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00337610

Purpose

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 18 Weeks Drug: Comparator: Placebo / Duration of Treatment 20 Weeks	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, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c after 18 weeks, safety and tolerability

Secondary Outcome Measures:

2-hour PPG and FPG after 18 weeks

Estimated Enrollment:	190
Study Start Date:	May 2006
Study Completion Date:	August 2007
Estimated Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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
Males
Females who are highly unlikely to become pregnant
Patients poorly controlled while taking one or two oral antidiabetic medications

Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus or history of ketoacidosis.
Patient required insulin therapy within the prior 8 weeks.
Patient is on or has been taking TZDs such as Actos(R) (pioglitazone) or Avandia(R) (rosiglitazone) or is on or has been taking Byetta(R) (exenatide) within the prior 12 weeks of the screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337610

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_017, MK0431-053
Study First Received:	June 14, 2006
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00337610
Health Authority:	United States: Food and Drug Administration

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
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009