Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes, Diabetes
Brief summary
The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.
Detailed description
The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).
Interventions
DRUGPPM-204
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men and women of non-childbearing potential, 18 to 70 years old * Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication * BMI \> 23 and \< 43 * For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%. * For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0%
Exclusion criteria
* Subjects requiring insulin therapy * Subjects currently receiving 2 or more oral antidiabetic medications * Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit * Subjects receiving warfarin * Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit * Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema. | — |
Countries
Argentina, Australia, Brazil, Canada, China, Croatia, Greece, Hong Kong, India, Italy, Mexico, Romania, Russia, Serbia and Montenegro, South Africa, Ukraine, United Kingdom, United States
Outcome results
None listed