A Study to Test MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

This study is currently recruiting participants.

Verified by Merck, April 2009

First Received: January 16, 2009 Last Updated: April 21, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00824616

Purpose

The purpose of this study is to test the effect MK0941 as add-on therapy for patients taking insulin for Type II Diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0941 Drug: Comparator: Placebo	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the effect of treatment with MK0941 compared with placebo on A1C when added to insulin [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo Comparator	Drug: Comparator: Placebo Mock titrated
1: Experimental MK0941	Drug: MK0941 Titrated to maximally effective dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Patient has a history of Type 1 Diabetes Mellitus or ketoacidosis
Patient is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
Patient has had surgery within 30 days of starting the study or has planned major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824616

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Florida
Call for Information	Recruiting
Miami, Florida, United States, 33169
United States, Illinois
Call for Information	Recruiting
Springfield, Illinois, United States, 62704
United States, New York
Call for Information	Recruiting
Syracuse, New York, United States, 13210
United States, Oklahoma
Call for Information	Recruiting
Oklahoma City, Oklahoma, United States, 73103-0000
United States, Pennsylvania
Call for Information	Recruiting
Uniontown, Pennsylvania, United States, 15401
United States, Texas
Call for Information	Recruiting
Irving, Texas, United States, 75039
Call for Information	Recruiting
Houston, Texas, United States, 77036
Colombia, Cundinamarca
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
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
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd.,	Recruiting
Auckland, New Zealand
Contact: David Woolner 64-9523-6075
Norway
MSD (Norge) AS	Recruiting
Drammen, Norway, 3011
Contact: Gunnar Saeter 47 32 20 7460
Peru, Lima
Merck Sharp & Dohme, Peru S.R.L.	Recruiting
Surquillo, Lima, Peru, LIMA 34
Contact: Jorge Vinces 511-411-5933
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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_516, MK0941-018
Study First Received:	January 16, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00824616 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009