A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: Aleglitazar

• Registration Number: NCT01042769
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Study Start: 2010-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Disposition First Submitted: 2016-07-20
• Disposition First Submitted QC: 2016-07-20
• Disposition First Posted: 2016-07-22
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7226

Inclusion Criteria

• Adults >18 years of age
• Type 2 diabetes mellitus
• Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Exclusion Criteria

• Estimated glomerular filtration rate <45 mL/min/1.73m2
• Concomitant treatment with a thiazolidinedione and/or fibrate
• Triglycerides >400 mg/dL
• Anaemia
• Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Aleglitazar	Aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	Throughout study, approximately 4.5 years

Secondary Outcome Measures

Name	Time	Method
Tolerability and long-term safety profile	Throughout study, approximately 4.5 years
Effects on other cardiovascular endpoints	Throughout study, approximately 4.5 years
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk	Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter