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A study to test if aleglitazar has a positive effect on the heart of patients with Type 2 diabetes and without cardiac disease, looking at the way the heart processes energy and fat.

A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of Aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin monotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001639-29-GB
Enrollment
Unknown
Registered
2012-05-10
Start date
2012-08-17
Completion date
Unknown
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Aleglitazar Product Code: RO0728804 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Aleglitazar CAS Number: 475479-34-6 Current Sponsor code: RO0728804 Other descriptive nam

Sponsors

F. Hoffmann-La Roche Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women 40 to 70 years of age; T2D patients either drug-naïve (i.e., treated with diet and exercise) or treated with stable metformin monotherapy; HbA1c = 7.0% and = 9.0%; absence of history of coronary artery disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: Treatment with fibrates, TZDs or insulin; intolerance to thiazolidinediones, and/or fibrates; known chronic diabetic complications; clinically significant hepatic disease and/or liver tests abnormalities; symptomatic congestive heart failure classified as NYHA class II-IV; malignancy within the past 5 years.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate if aleglitazar improves cardiac energetics, by means of MRS, in uncomplicated T2D patients with no history of CAD, after 6 weeks of treatment;Secondary Objective: • To evaluate if aleglitazar improves left ventricular diastolic function, measured by means of mitral inflow, tissue Doppler imaging and MRI, in uncomplicated T2D patients with no history of CAD, after 6 weeks of treatment • To evaluate if aleglitazar reduces cardiac and hepatic triglyceride content, by means of 1H-MRS, in uncomplicated T2D patients with no history of CAD;Primary end point(s): Change in cardiac PCr/ATP ratio using 31phosphorus MRS, after 6 weeks of treatment with aleglitazar versus treatment with PLO, derived as the difference of the PCr/ATP ratio between week 6 and baseline in each treatment period.;Timepoint(s) of evaluation of this end point: At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo).—

Secondary

MeasureTime frame
Secondary end point(s): - Change of left ventricular diastolic function measured by means of mitral inflow, tissue Doppler Imaging and MRI, after 6 weeks of treatment with aleglitazar versus treatment with PLO. - Change in cardiac and hepatic triglyceride content, by means of MRS, after 6 weeks of treatment. ;Timepoint(s) of evaluation of this end point: At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo).—

Countries

United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026