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

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Roche

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Placebo
Drug: Aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01042769
2009-012269-71
BC22140

Details and patient eligibility

About

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.

Enrollment

7,226 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

7,226 participants in 2 patient groups, including a placebo group

Aleglitazar
Experimental group
Treatment:
Drug: Aleglitazar
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

812

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Data sourced from clinicaltrials.gov

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