Status:
TERMINATED
Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 diab...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00425919
Start Date
January 1 2007
End Date
October 1 2007
Last Update
December 27 2007
Active Locations (68)
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1
Artesia, California, United States, 90701
2
Los Angeles, California, United States, 90057
3
Chipley, Florida, United States, 32428
4
Destin, Florida, United States, 32541