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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:
ClinicalTrials.gov Identifier:
NCT00425919
First Posted: January 23, 2007
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double
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

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
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425919


  Show 68 Study Locations
Sponsors 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

ClinicalTrials.gov Identifier: NCT00425919     History of Changes
Other Study ID Numbers: 3180A1-200
First Submitted: January 19, 2007
First Posted: January 23, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

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