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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00425919
Other study ID # 3180A1-200
Secondary ID
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
Est. primary completion date
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


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.
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