Trial information
A Study of Aleglitazar in Patients With Type 2 Diabetes
Status: Completed
Protocol number: BM17864
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study to investigate the effect of aleglitazar on glycemic control in patients with Type 2 diabetes mellitus.
Brief summary: This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: aleglitazar
Primary outcome: 1. Absolute change from baseline in HbAlc Time frame: 16 weeks
Key secondary outcomes: 1. Absolute change from baseline in FPG, HbAlc response rate, insulin sensitivity, beta cell function and cardiovascular markers. Time frame: 16 weeks
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes, diagnosed >=1 month of screening;
- either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
- HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
Exclusion criteria:
- type 1 diabetes;
- currently or previously treated with insulin, a thiazolidinedione, or a dual PPAR agonist;
- clinically significant cardiovascular disease;
- CHF NYHA 3-4.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/17/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
China
Italy
- Bologna
- Genova
- Perugia
- Siena
- Torino
Mexico
- Aguascalientes
- Chihuahua
- Cuernavaca
- Durango
- Guadalajara
- Mexico City
- Monterrey
- Pachuca
Romania
- Bucharest
- Cluj-Napoca
- Galati
- Ploiesti
Russian Federation
- Moscow
- Saratov
- St Petersburg
Serbia and Montenegro
United States
- Beverly Hills, CA
- Palm Springs, CA
- San Diego , CA
- Chiefland, FL
- Hollywood, FL
- West Palm Beach, FL
- Augusta, GA
- Idaho Falls, ID
- Baton Rouge, LA
- Olive Branch, MS
- New Hyde Park, NY
- Johnson City, TN
- Spokane , WA
