Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00425919
• Other study ID #: 3180A1-200
• Status: Terminated
• Phase: Phase 2
• First received: January 19, 2007
• Last updated: December 18, 2007
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• PPM-204

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Croatia,  Former Serbia and Montenegro,  Greece,  Hong Kong,  India,  Italy,  Mexico,  Romania,  Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose
Secondary	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.