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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
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
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Washington
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Argentina
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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
State/province [12] 0 0
Ramos Mejia, Pcia de Bs.
Country [13] 0 0
Brazil
State/province [13] 0 0
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
Country [20] 0 0
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
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
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
Country [27] 0 0
India
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Kerala
Country [28] 0 0
India
State/province [28] 0 0
Maharashtra
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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
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Mexico
State/province [33] 0 0
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
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Mexico
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Tlapan
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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
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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
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00425919