Dose-Range Finding Study for MK0893 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00479466

Purpose

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0893 Drug: Comparator: metformin Drug: Comparator: placebo (unspecified)	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

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, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:

The effect of treatment with a range of doses of MK0893 on fasting plasma glucose after 12 weeks. [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimate differences in glucose-lowering efficacy on HbA1c. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	705
Study Start Date:	June 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: MK0893 80 mg tablet once daily.	Drug: MK0893 MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
2: Experimental Arm 2: MK0893 60 mg tablet once daily.	Drug: MK0893 MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
3: Experimental Arm 3: MK0893 40 mg tablet once daily..	Drug: MK0893 MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
4: Experimental Arm 4: MK0893 20 mg tablet once daily.	Drug: MK0893 MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
5: Active Comparator Arm 5: Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.	Drug: Comparator: metformin Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
6: Placebo Comparator Arm 6: Pbo tablets. 12 week treatment period.	Drug: Comparator: placebo (unspecified) MK0893 80 mg Pbo tablet; 60 mg Pbo tablet; 40 mg Pbo tablet; 20 mg Pbo tablet, once daily.

Eligibility

Criteria

Inclusion Criteria:

Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479466

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

Colombia, Cundinamarca
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
Germany
Msd Sharp & Dohme Gmbh	Recruiting
Haar, Germany, 85540
Contact: Thomas Lang 49-89-4561-1536
Mexico, D.F.
Merck Sharp & Dohme De Mexico, S.A. De C.V.	Recruiting
Mexico, D.F., Mexico, 1090
Contact: Juan Diaz 52-55-5481-9825

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_526, MK0893-008
Study First Received:	May 25, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00479466
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009