Clinical trial NCT00425919: Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Type 2 Diabetes
Diabetes
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Fasting Plasma Glucose
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Chipley
country: United States
state: Florida
city: Destin
country: United States
state: Florida
city: Marianna
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Omaha
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Austin
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Corrientes
country: Argentina
city: La Plata
country: Argentina
city: Mar del Plata Pcia de Bs. As
country: Argentina
city: Ramos Mejia, Pcia de Bs.
country: Argentina
city: Daws Park
country: Australia
state: South Australia
city: Keswick
country: Australia
state: South Australia
city: Box Hill
country: Australia
state: Victoria
city: Vila Clementino - Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Charlottetown
country: Canada
state: Prince Edward Island
city: Laval
country: Canada
state: Quebec
city: Saint-Janvier
country: Canada
state: Quebec
city: Beijing
country: China
city: Beijing
country: China
city: Krapinske Toplice
country: Croatia
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Belgrade
country: Former Serbia and Montenegro
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Wanchai
country: Hong Kong
city: Bangalore
country: India
state: Karnataka
city: Cochin
country: India
state: Kerala
city: Pune
country: India
state: Maharashtra
city: Chennai
country: India
state: Tamil nadu
city: Vellore
country: India
state: Tamil Nadu
city: Catanzaro
country: Italy
city: Pisa
country: Italy
city: Aguascalientes
country: Mexico
city: Mexico D.F.
country: Mexico
city: Mexico DF
country: Mexico
city: Miguel Hidalgo
country: Mexico
city: Monterrey N.L
country: Mexico
city: Tlapan
country: Mexico
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Benoni
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Temba
country: South Africa
state: North West Province
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Poltava
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Dundee
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Livingston
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Argentina, Scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Canada, clintrialparticipation@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Chile, scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Croatia, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hong Kong, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezzlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Russia, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Serbia, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK/Great Britian, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Ukraine, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: