Clinical trial NCT00057317: Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2003-04-01
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.


Eligibility criteria: Inclusion Criteria:

* Age 35 to 75
* Type 2 diabetes for longer than 3 months
* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
* FPG (fasting plasma glucose) greater than 126 mg/dL at screening
* BMI (body mass index) less than 40 kg/square meter

Exclusion Criteria:

* Type I diabetes
* Type 2 diabetes patients currently treated with insulin
* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
* Impaired liver or kidney function
* Triglycerides greater than 600 mg/dL
* Uncontrolled hypertension
* Pregnant or lactating women
* Women not using adequate contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Encino
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fremont
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
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state: California
city: Modesto
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Bruno
country: United States
state: California
city: Santa Rosa
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state: California
city: Sunnyvale
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state: California
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state: Connecticut
city: Norwalk
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state: Connecticut
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state: Delaware
city: Hollywood
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state: Florida
city: Jacksonville
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state: Florida
city: Ocala
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state: Florida
city: West Palm Beach
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state: Florida
city: Atlanta
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state: Georgia
city: Lawrenceville
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state: Georgia
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state: Hawaii
city: Indianapolis
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state: Indiana
city: Overland Park
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state: Kansas
city: New Orleans
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state: Louisiana
city: Boston
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state: Massachusetts
city: Kansas City
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state: Missouri
city: St. Louis
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state: Missouri
city: St. Louis
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state: Missouri
city: Billings
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state: Montana
city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
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city: Albuquerque
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state: New Mexico
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city: New Hyde Park
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city: Rochester
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city: Charlotte
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state: North Carolina
city: Durham
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state: North Carolina
city: Greenville
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state: North Carolina
city: Morrisville
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state: North Carolina
city: Portland
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city: Tualatin
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state: Oregon
city: Camp Hill
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state: Pennsylvania
city: Connellsville
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: East Providence
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state: Rhode Island
city: Greer
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state: South Carolina
city: Memphis
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state: Tennessee
city: Dallas
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state: Texas
city: El Paso
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state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
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state: Texas
city: San Antonio
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state: Texas
city: San Antonio
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state: Texas
city: Lebanon
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state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Courtice
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte-foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St. John's
country: Canada
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Voru
country: Estonia
city: Ogre
country: Latvia
city: Talsi
country: Latvia
city: Tukums
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Merida
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca, Hidalgo
country: Mexico
city: Tijuana
country: Mexico
city: Panama
country: Panama
city: Ponce
country: Puerto Rico
city: Arad
country: Romania
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Galati
country: Romania
city: Ploiesti
country: Romania
city: Targoviste
country: Romania
city: Tirgu-mures
country: Romania
city: Bracknell
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
References: