Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

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.

Official Title

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes

Conditions

Diabetes Mellitus, Type 2

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Fasting Plasma Glucose

Secondary Outcome Measures:

• 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 fattty acids, hs C-reactive protein, adiponectin, edema.

Study Start

January 2007; Expected completion: January 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 70 Years
• Genders Eligible for Study: Both

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)

Total Enrolment

500

Contact Details

Australian Locations and Contacts:

• Keswick, South Australia, 5035, Australia; Recruiting
• Daws Park, South Australia, 5041, Australia; Recruiting
• Box Hill, Victoria, 3128, Australia; Recruiting
• Principal Investigator, For Australia: medinfo@wyeth.com
• Trial Manager, International: clintrialparticipation@wyeth.com