Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGMK0478 (muraglitazar)
DRUGComparator: placebo
Sponsors
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in daily dose requirements of insulin after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Outcome results
None listed