An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)(TERMINATED)
This study has been terminated.
Information provided by:
Merck Sharp & Dohme Corp.
First received: August 12, 2005
Last updated: May 20, 2013
Last verified: May 2013
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.
Type 2 Diabetes Mellitus
Drug: MK0478 (muraglitazar)
Drug: Comparator: placebo
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Study to Assess the Efficacy and Tolerability of MK0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes
Primary Outcome Measures:
- The difference in daily dose requirements of insulin after 24 weeks
Secondary Outcome Measures:
- (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
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||November 2005 (Final data collection date for primary outcome measure)
The duration of treatment is 30 weeks.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.)
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130806
Merck Sharp & Dohme Corp.
||Merck Sharp & Dohme Corp.
No publications provided
||Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2005
||May 20, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 28, 2014
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders