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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00425919 |
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Date of registration:
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19/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
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Scientific title:
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A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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500 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00425919 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Canada
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China
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Croatia
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Former Serbia and Montenegro
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Greece
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Hong Kong
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India
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Italy
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Mexico
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Romania
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Russian Federation
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South Africa
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Canada, clintrialparticipation@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Croatia, WPBUMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Russia, WVPIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Brazil, xavierl@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hong Kong, medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Romania, WVPIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For South Africa, ZAFinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For UK/Great Britian, ukmedinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Greece, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Australia, medinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Austria, WPVIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Argentina, Scheima@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Chile, scheima@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For China, medinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, descresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Mexico, gomezzlj@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Serbia, WPVIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Ukraine, WVPIMED@wyeth.com |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Drug: PPM-204
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Primary Outcome(s)
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Fasting Plasma Glucose
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Secondary Outcome(s)
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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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Secondary ID(s)
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3180A1-200
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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