A Study of Aleglitazar in Patients with Stable Cardiovascular Disease and Glucose Abnormalities

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus-E749 Disorder of carbohydrate metabolism, unspecified-I519 Heart disease, unspecified; Non-insulin-dependent diabetes mellitus; Disorder of carbohydrate metabolism, unspecified; Heart disease, unspecified; E11; E749; I519

• Registration Number: PER-002-13
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Male and female patients with established evidence of stable CVD defined as at least one of the following groups of criteria (A or B):
A. Age ≥ 40 years with history of a prior CV event (with onset ≥ 3 months prior to randomization and stable in the Investigator’s judgment)
B. Age ≥ 55 years with evidence of CVD (stable in the Investigator’s judgment), defined as at least one of the following: Coronary disease, Cerebrovascular disease or Peripheral arterial disease as defined by protocol.
• Patients with glucose abnormalities based on one of the following A-B criteria:
A. Established Type 2 Diabetes mellitus (T2D) according to the 2010 ADA criteria. Treatment may include diet alone, or any approved glucose-lowering therapies except for thiazolidinediones (TZDs)
B. No fulfillment of criteria A but evidence of glucose abnormalities.
• Ability and willingness to give written informed consent and to comply with the requirements of the study.
• Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines.

Exclusion Criteria

• Current treatment with a TZD or fibrate
• Prior intolerance to a TZD or fibrate
• Previous participation in a trial with aleglitazar
• Other types of diabetes
• Inadequate liver, hematologic or renal function as defined by protocol
• Symptomatic congestive heart failure classified as NYHA class II-IV
• Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding the randomization
• Peripheral edema which in the judgment of the investigator is believed to be clinically severe and of cardiac origin
• History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
• Currently scheduled for arterial revascularization procedures
• Systemic corticosteroid therapy for > 2 weeks, within 3 months prior to screening
• Diagnosed or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
• Women with a positive pregnancy test, breast feeding or of childbearing potential not using medically approved, highly effective methods of contraception
• Participation in any clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified