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.

• Register: EUCTR
• Last refreshed on: 10 March 2014
• Main ID: EUCTR2012-001639-29-GB
• Date of registration: 10/05/2012
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 17/08/2012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001639-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

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 name: dual PPAR alpha/gamma agonist
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo).

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.

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo).

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.

Secondary ID(s)

BC25445

Source(s) of Monetary Support

F.Hoffmann-La Roche Ltd.