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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042769
• Other study ID #: BC22140
• Secondary ID: 2009-012269-71
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7226
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Aleglitazar
aleglitazar 150 micrograms po daily
• Placebo
placebo control po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Czech Republic,  Denmark,  France,  Germany,  Grenada,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke		Throughout study, approximately 4.5 years	No
Secondary	Effects on other cardiovascular endpoints		Throughout study, approximately 4.5 years	No
Secondary	Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk		Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter	No
Secondary	Tolerability and long-term safety profile		Throughout study, approximately 4.5 years	No