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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	126
Study Start Date:	February 2008
Study Completion Date:	January 2009
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) Other Names: Sitagliptin JANUVIA™ MK0431 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) Other Names: Sitagliptin JANUVIA™ MK0431 Drug: Comparator: Metformin hydrochloride Metformin hydrochloride 2000 mg tablet qd po for the duration of the study (4 weeks) Other Names: Metformin GLUCOPHAGE® 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) Other Names: Metformin GLUCOPHAGE® 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00631488 History of Changes
Other Study ID Numbers:	2007_646, MK0893-015
Study First Received:	February 21, 2008
Last Updated:	February 5, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012