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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: aleglitazar
Drug: Actos
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 332
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 2 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 3 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 4 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Active Comparator: 5 Drug: Actos
45mg po daily
Placebo Comparator: 6 Drug: Placebo
po daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 PPAR agonist;
  • clinically significant cardiovascular disease;
  • CHF NYHA 3-4.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388518

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00388518     History of Changes
Other Study ID Numbers: BM17864
Study First Received: October 16, 2006
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014