A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes - Full Text View

Purpose

This study will test the effectiveness and safety of treatment with MK0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0893 Drug: Comparator: sitagliptin phosphate Drug: Comparator: Metformin hydrochloride Drug: Comparator: Placebo (Unspecified)	Phase II

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 Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin 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 of MK0893 in combination with sitagliptin or with metformin compared to the combination of sitagliptin and metformin on 24-hour weighted mean glucose levels after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of MK0893 after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	126
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Arm 1: study medication/sitagliptin + Pbo	Drug: MK0893 MK0893 40mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: sitagliptin phosphate sitagliptin phosphate 100 mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: Placebo (Unspecified) Matching Placebo for each arm of the trial
2 Arm 2: sitagliptin/metformin + Pbo	Drug: Comparator: sitagliptin phosphate sitagliptin phosphate 100 mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: Metformin hydrochloride Metformin hydrochloride 2000 mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: Placebo (Unspecified) Matching Placebo for each arm of the trial
3 Arm 3: study medication/metformin + Pbo	Drug: MK0893 MK0893 40mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: Metformin hydrochloride Metformin hydrochloride 2000 mg tablet qd po for the duration of the study (4 weeks) Drug: Comparator: Placebo (Unspecified) Matching Placebo for each arm of the trial

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Patients have a history of Type 1 Diabetes Mellitus
Patients taking insulin or TZD (PPAR-gamma agonist)
Patients who have a contraindication to metformin or sitagliptin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631488

Contacts


Contact: Toll Free Number	1-888-577-8839

Locations


United States, California
	Call for Information	Recruiting
	Walnut Creek, California, United States, 94598

United States, Florida
	Call for Information	Recruiting
	Miami, Florida, United States, 33169

United States, Kentucky
	Call for Information	Recruiting
	Louisville, Kentucky, United States, 40213

United States, New Jersey
	Call for Information	Recruiting
	Toms River, New Jersey, United States, 08753

United States, North Carolina
	Call for Information	Recruiting
	Winston-Salem, North Carolina, United States, 27103-3914
	Call for Information	Recruiting
	Charlotte, North Carolina, United States, 28211

Denmark
	Merck Sharp & Dohme	Recruiting
	Glostrup, Denmark, 2600
	Contact: Christina Wengel 45-43-28-77-90

France
	Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
	Paris Cedex 8, France, 75114
	Contact: Jean-Marie Goehrs 33-1-4754-89-90

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

Spain
	Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
	Madrid, Spain, 28027
	Contact: Jorge Gonzalez-Esteban 34-91-3210-728

Sweden
	Merck Sharp & Dohme (Sweden) AB	Recruiting
	Sollentuna, Sweden, 192 07
	Contact: Roger Juhlin 46-8-626-1 458

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_646, MK0893-015
First Received:	February 21, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00631488
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 November 30, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00631488