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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00425919
Ethics application status
Date submitted
19/01/2007
Date registered
19/01/2007
Date last updated
18/12/2007

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
Treatment: Drugs - PPM-204

Treatment: Drugs: PPM-204


Intervention code [1] 0 0
Treatment: Drugs
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
Gender
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
Terminated
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
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
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
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
State/province [12] 0 0
Ramos Mejia, Pcia de Bs.
Country [13] 0 0
Brazil
State/province [13] 0 0
Vila Clementino - Sao Paulo
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Prince Edward Island
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
Croatia
State/province [19] 0 0
Krapinske Toplice
Country [20] 0 0
Croatia
State/province [20] 0 0
Rijeka
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Former Serbia and Montenegro
State/province [22] 0 0
Belgrade
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Greece
State/province [24] 0 0
Thessaloniki
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Wanchai
Country [26] 0 0
India
State/province [26] 0 0
Karnataka
Country [27] 0 0
India
State/province [27] 0 0
Kerala
Country [28] 0 0
India
State/province [28] 0 0
Maharashtra
Country [29] 0 0
India
State/province [29] 0 0
Tamil nadu
Country [30] 0 0
India
State/province [30] 0 0
Tamil Nadu
Country [31] 0 0
Italy
State/province [31] 0 0
Catanzaro
Country [32] 0 0
Italy
State/province [32] 0 0
Pisa
Country [33] 0 0
Mexico
State/province [33] 0 0
Aguascalientes
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico D.F.
Country [35] 0 0
Mexico
State/province [35] 0 0
Mexico DF
Country [36] 0 0
Mexico
State/province [36] 0 0
Miguel Hidalgo
Country [37] 0 0
Mexico
State/province [37] 0 0
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
State/province [40] 0 0
Cluj-Napoca
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
St. Petersburg
Country [43] 0 0
South Africa
State/province [43] 0 0
Eastern Cape
Country [44] 0 0
South Africa
State/province [44] 0 0
Gauteng
Country [45] 0 0
South Africa
State/province [45] 0 0
North West Province
Country [46] 0 0
Ukraine
State/province [46] 0 0
Kharkiv
Country [47] 0 0
Ukraine
State/province [47] 0 0
Kyiv
Country [48] 0 0
Ukraine
State/province [48] 0 0
Poltava
Country [49] 0 0
Ukraine
State/province [49] 0 0
Uzhgorod
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Dundee
Country [51] 0 0
United Kingdom
State/province [51] 0 0
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00425919
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