Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Wyeth

Status and phase

Terminated

Phase 2

Conditions

Diabetes Mellitus

Treatments

Drug: PPM-204

Study type

Interventional

Funder types

Industry

Identifiers

NCT00425919

3180A1-200

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)