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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. )

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00425919
  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 II

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

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
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 Locations

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor     Wyeth    
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


Study ID Numbers:   3180A1-200
First Received:   January 19, 2007
Last Updated:   December 18, 2007
ClinicalTrials.gov Identifier:   NCT00425919
Health Authority:   United States: Food and Drug Administration

Keywords provided by Wyeth:
Type 2 Diabetes  
Diabetes  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 03, 2008




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