E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo). |
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E.5.2 | 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.
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At Week 6 and Week 18 (after 6 weeks of treatment with aleglitazar or placebo). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as the date when the last patient, last visit (LPLV)
occurs. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |