Dose Range Finding Study of MK0941 in Patients With Type 2 Diabetes on Insulin - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00767000

Purpose

The purpose of this study is to test the effect of MK0941 as add-on therapy for patients taking insulin for Type 2 Diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Comparator: 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, Safety/Efficacy Study
Official Title:	A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding 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:

HbA1c reduction compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect on 2-hour post meal glucose level compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	550
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0941	Drug: Comparator: MK0941 Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
2: Experimental MK0941	Drug: Comparator: MK0941 Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
3: Experimental MK0941	Drug: Comparator: MK0941 Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
4: Experimental MK0941	Drug: Comparator: MK0941 Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
5: Placebo Comparator Placebo	Drug: Comparator: Placebo Placebo to MK0941

Eligibility

Criteria

Inclusion Criteria:

Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes

Exclusion Criteria:

Patient has any history of Type 1 Diabetes
Patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
Patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767000

Contacts

Contact: Toll Free Number

1-888-577-8839

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:	2008_557, MK0941-007
Study First Received:	October 3, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00767000
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009