A Study of Aleglitazar in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00388518
First received: October 16, 2006
Last updated: July 7, 2014
Last verified: July 2014

October 16, 2006
July 7, 2014
November 2006
March 2008   (final data collection date for primary outcome measure)
Absolute change from baseline in HbAlc [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Absolute change from baseline in HbA1c at end of treatment
Complete list of historical versions of study NCT00388518 on ClinicalTrials.gov Archive Site
  • Absolute change from baseline in FPG, HbAlc response rate, insulin sensitivity, beta cell function and cardiovascular markers. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Absolute change from baseline in FPG; HbA1c response rate; insulin sensitivity and beta cell function; cardiovascular markers. Safety: AEs, laboratory parameters
Not Provided
Not Provided
 
A Study of Aleglitazar in Patients With Type 2 Diabetes
A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokine tics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be r andomised 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 admini stered starting from a dose of 0.05mg po daily, and Actos will be administered a t a dose of 45mg once daily. The anticipated time on study treatment is 3-12 mon ths, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: aleglitazar
    Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
  • Drug: Actos
    45mg po daily
  • Drug: Placebo
    po daily
  • Experimental: 1
    Intervention: Drug: aleglitazar
  • Experimental: 2
    Intervention: Drug: aleglitazar
  • Experimental: 3
    Intervention: Drug: aleglitazar
  • Experimental: 4
    Intervention: Drug: aleglitazar
  • Active Comparator: 5
    Intervention: Drug: Actos
  • Placebo Comparator: 6
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Greece,   Hong Kong,   Italy,   Mexico,   Romania,   Russian Federation,   Serbia
 
NCT00388518
BM17864
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP