Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Phase 2

Terminated

• Conditions: Diabetes Mellitus

• Registration Number: NCT00425919
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-23
• Study Completion: 2007-10
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose

Secondary Outcome Measures

Name	Time	Method
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.