An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)
Phase 3
Terminated
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00130806
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
The duration of treatment is 30 weeks.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The difference in daily dose requirements of insulin after 24 weeks
- Secondary Outcome Measures
Name Time Method (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