Diabetes Mellitus Type 2
Conditions
Brief summary
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
Interventions
DRUGMK0533
Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
DRUGComparator: Placebo (unspecified)
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
pioglitazone 45mg. Study period is a total of 24 wks.
Sponsors
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
* Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels * Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
Exclusion criteria
* Patients taking any medicines that affect body fluid level such as a diuretic or water pill * Patients taking niacin or other certain medications * Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders * Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fluid gain from baseline after 12 weeks | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose after 12 weeks | 12 weeks |
Outcome results
None listed