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: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Actos
Drug: Placebo
Drug: aleglitazar
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 26, 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 August 26, 2014