Clinical trial NCT00057304: Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & 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
Enrollment: 190
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period.

treatment
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 2 to 5 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: Hollywood
country: United States
state: Florida
city: Durham
country: United States
state: North Carolina
city: Morrisville
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: Lebanon
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Voru
country: Estonia
city: Chihuahua, Chih.
country: Mexico
city: Guadalajara, JAL.
country: Mexico
city: Guadalajara
country: Mexico
city: Merida
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: 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: Craiova
country: Romania
city: Galati
country: Romania
city: Ploiesti
country: Romania
city: Targoviste
country: Romania
city: Tirgu-mures
country: Romania
city: Meyrin
country: Switzerland
city: Bracknell
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
References: