A Study of Aleglitazar in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: aleglitazar; Drug: Actos; Drug: Placebo

• Registration Number: NCT00388518
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Study Start: 2006-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Disposition First Submitted: 2016-06-28
• Disposition First Submitted QC: 2016-06-28
• Disposition First Posted: 2016-06-30
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aleglitazar 1	aleglitazar	-
Actos	Actos	-
Placebo	Placebo	-
Aleglitazar 3	aleglitazar	-
Aleglitazar 2	aleglitazar	-
Aleglitazar 4	aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in Hemoglobin A1c (HbA1c)	16 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs), laboratory parameters.	Throughout study
Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.	16 weeks