Sitagliptin Comparative Study in Patients With Type 2 Diabetes - Full Text View

Purpose

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: sitagliptin phosphate Drug: metformin hydrochloride	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), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

gastrointestinal tolerance [ Time Frame: Over 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	1000
Study Start Date:	March 2007
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: drug	Drug: sitagliptin phosphate (1) sitagliptin 100mg tablet qd for a 24-wk treatment period
2: Active Comparator Arm 2: Active comparator	Drug: metformin hydrochloride (4) Metformin 500mg tablets qd for a 24-wk treatment period.

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 inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449930

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:	2006_561, MK0431-049
First Received:	March 19, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00449930
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

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00449930