A Study of Aleglitazar in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00388518

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Aleglitazar

U.S. FDA Resources

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 Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	Drug: aleglitazar Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
2: Experimental	Drug: aleglitazar Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
3: Experimental	Drug: aleglitazar Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
4: Experimental	Drug: aleglitazar Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
5: Active Comparator	Drug: Actos 45mg po daily
6: Placebo Comparator	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, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BM17864
Study First Received:	October 16, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00388518 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010