Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.
Interventions
DRUGMK0767
Duration of Treatment: 52 Weeks
DRUGComparator: placebo (unspecified)
Duration of Treatment: 52 Weeks
Duration of Treatment: 52 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients are men and non-pregnant women ages 21 to 78 years * Patients either not on antihyperglycemic medications (\>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study
Exclusion criteria
* Patient has history of type 1 diabetes mellitus and or history of ketoacidosis * Patients undergoing surgery within 30 days of Visit 1 * Patients taking Warfin or Warfin-like anticoagulants * Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks. | over the course of 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| MK0767 will be safe and well tolerated. | over the course of 52 weeks |
Outcome results
None listed