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

Purpose

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0431, sitagliptin phosphate Drug: Comparator: placebo, pioglitazone	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK-0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimeperide Alone or in Combination With Metformin

Further study details as provided by Merck:

Primary Outcome Measures:

After 24 weeks, reduction in HbA1c [ Time Frame: 24 weeks ]
Safety and Tolerability

Secondary Outcome Measures:

After 24 weeks, greater reduction in glycemic control [ Time Frame: 24 weeks ]

Estimated Enrollment:	360
Study Start Date:	April 2005

Detailed Description:

The duration of treatment is 73 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Type 2 Diabetes Mellitus

Exclusion Criteria:

Patients with Type 1 Diabetes Mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106704

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Publications:

Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. Epub 2007 Jun 26.

Study ID Numbers:	2005_009
First Received:	March 29, 2005
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00106704
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

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 September 23, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00106704