Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
This study has been terminated.
(Study terminated as a result of interim analysis not meeting predetermined criteria.)
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00425919
First received: January 19, 2007
Last updated: December 18, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: PPM-204 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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.
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2007 |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425919
Show 68 Study Locations
Show 68 Study LocationsSponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Argentina, Scheima@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Brazil, xavierl@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Canada, clintrialparticipation@wyeth.com |
| Principal Investigator: | Trial Manager | For Chile, scheima@wyeth.com |
| Principal Investigator: | Trial Manager | For China, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Croatia, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Greece, decresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Hong Kong, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Mexico, gomezzlj@wyeth.com |
| Principal Investigator: | Trial Manager | For Romania, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Russia, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Serbia, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Ukraine, WVPIMED@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00425919 History of Changes |
| Other Study ID Numbers: | 3180A1-200 |
| Study First Received: | January 19, 2007 |
| Last Updated: | December 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Type 2 Diabetes Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013