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

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

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: Comparator: metformin hydrochloride	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Nausea and Vomiting

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment:	1050
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 Drug	Drug: sitagliptin phosphate (1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
2: Active Comparator Active comparator	Drug: Comparator: metformin hydrochloride (4) Metformin 500mg tablets once daily (q.d.) 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

General Inclusion Criteria:

Patient has type 2 diabetes mellitus (T2DM)
Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General 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

Additional 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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_561, MK0431-049
Study First Received:	March 19, 2007
Results First Received:	June 23, 2009
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00449930 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 02, 2009