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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PPM-204

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Type 2 Diabetes, Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Outcomes

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 fatty acids, hs C-reactive protein, adiponectin, edema.

Full Information

NCT ID

NCT00425919

First Posted

January 19, 2007

Last Updated

December 18, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00425919

Brief Title

Study Evaluating PPM-204 In Subjects 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Why Stopped

Study terminated as a result of interim analysis not meeting predetermined criteria.

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

Keywords

Type 2 Diabetes, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

500 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

PPM-204

Primary Outcome Measure Information:

Title

Fasting Plasma Glucose

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: