Clinical trial NCT00388518: A Study of Aleglitazar in Patients With Type 2 Diabetes
Official title: A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 Peroxisome Proliferator Activated Receptor (PPAR) agonist;
* clinically significant cardiovascular disease;
* Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.

Primary outcomes:
measure: Absolute change from baseline in Hemoglobin A1c (HbA1c)
timeFrame: 16 weeks
Secondary outcomes:
measure: Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.
timeFrame: 16 weeks
measure: Adverse Events (AEs), laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: Chiefland
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Hamilton
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: Johnson City
country: United States
state: Tennessee
city: Spokane
country: United States
state: Washington
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Bologna
country: Italy
city: Genova
country: Italy
city: Napoli
country: Italy
city: Olbia
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Torino
country: Italy
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Cuernavaca
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Galati
country: Romania
city: Ploiesti
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.