An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130806
Recruitment Status : Terminated
First Posted : August 16, 2005
Last Update Posted : September 7, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MK0478 (muraglitazar) Drug: Comparator: placebo Phase 3

Detailed Description:
The duration of treatment is 30 weeks.

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Efficacy and Tolerability of MK0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes
Study Start Date : September 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The difference in daily dose requirements of insulin after 24 weeks

Secondary Outcome Measures :
  1. (a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)

Exclusion Criteria:

  • People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130806

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00130806     History of Changes
Other Study ID Numbers: 0478-065
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases