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

Tracking Information

First Received Date ^ICMJE

February 21, 2008

Last Updated Date

February 5, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00631488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: MK0893
Drug: Comparator: sitagliptin phosphate
Drug: Comparator: Metformin hydrochloride
Drug: Comparator: Placebo (Unspecified)

Study Arms / Comparison Groups

Other: Arm 1: study medication/sitagliptin + Pbo
Other: Arm 2: sitagliptin/metformin + Pbo
Other: Arm 3: study medication/metformin + Pbo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

126

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00631488

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_646, MK0893-015

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP