A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01042769 |
Recruitment Status
:
Completed
First Posted
: January 6, 2010
Last Update Posted
: November 2, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 2 | Drug: Aleglitazar Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7226 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Aleglitazar |
Drug: Aleglitazar
aleglitazar 150 micrograms po daily
|
Placebo Comparator: Placebo |
Drug: Placebo
placebo control po daily
|
- Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ]
- Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ]
- Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk [ Time Frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter ]
- Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042769

Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01042769 History of Changes |
Other Study ID Numbers: |
BC22140 2009-012269-71 |
First Posted: | January 6, 2010 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Acute Coronary Syndrome Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |