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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00425919




Registration number
NCT00425919
Ethics application status
Date submitted
19/01/2007
Date registered
23/01/2007
Date last updated
27/12/2007

Titles & IDs
Public title
Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
3180A1-200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting Plasma Glucose
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Daws Park
Recruitment hospital [2] 0 0
- Keswick
Recruitment hospital [3] 0 0
- Box Hill
Recruitment postcode(s) [1] 0 0
5041 - Daws Park
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
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Argentina
State/province [8] 0 0
Buenos Aires
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Argentina
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Corrientes
Country [10] 0 0
Argentina
State/province [10] 0 0
La Plata
Country [11] 0 0
Argentina
State/province [11] 0 0
Mar del Plata Pcia de Bs. As
Country [12] 0 0
Argentina
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Ramos Mejia, Pcia de Bs.
Country [13] 0 0
Brazil
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Vila Clementino - Sao Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Prince Edward Island
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Canada
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Quebec
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China
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Beijing
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Croatia
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Krapinske Toplice
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Croatia
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Rijeka
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Croatia
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Zagreb
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Former Serbia and Montenegro
State/province [22] 0 0
Belgrade
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Greece
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Athens
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Greece
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Thessaloniki
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Hong Kong
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Wanchai
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India
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Karnataka
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India
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Kerala
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India
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Maharashtra
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India
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Tamil nadu
Country [30] 0 0
India
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Tamil Nadu
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Italy
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Catanzaro
Country [32] 0 0
Italy
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Pisa
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Mexico
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Aguascalientes
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Mexico
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Mexico D.F.
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Mexico
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Mexico DF
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Mexico
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Miguel Hidalgo
Country [37] 0 0
Mexico
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Monterrey N.L
Country [38] 0 0
Mexico
State/province [38] 0 0
Tlapan
Country [39] 0 0
Romania
State/province [39] 0 0
Bucuresti
Country [40] 0 0
Romania
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Cluj-Napoca
Country [41] 0 0
Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Eastern Cape
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South Africa
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Gauteng
Country [45] 0 0
South Africa
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North West Province
Country [46] 0 0
Ukraine
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Kharkiv
Country [47] 0 0
Ukraine
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Kyiv
Country [48] 0 0
Ukraine
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Poltava
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Ukraine
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Uzhgorod
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Livingston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.