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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:
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
History of Changes

January 19, 2007
December 18, 2007
January 2007
Not Provided
Fasting Plasma Glucose
Same as current
Complete list of historical versions of study NCT00425919 on ClinicalTrials.gov Archive Site
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.
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.
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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of 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.

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).
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus
Drug: PPM-204
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
500
October 2007
Not Provided

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00425919
3180A1-200
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP