E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes with moderate renal function impairment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007649 |
E.1.2 | Term | Cardiovascular disorder |
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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 determine reversibility of eGFRMDRD decrease following 52 weeks of 150 μg aleglitazar treatment and 8 weeks follow up observation after the last study medication, in patients with T2D and moderate renal function impairment (CKD stage 3), in comparison with Actos® treatment. |
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E.2.2 | Secondary objectives of the trial |
•To determine the effects of 52 weeks of 150 µg aleglitazar treatment on eGFRMDRD, in patients with T2D and moderate renal function impairment (CKD stage 3). •To determine the effects of 150 µg aleglitazar treatment on lipid profile.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥ 18 years at screening visit. 2. Males and females diagnosed with T2D, based on the WHO criteria, for at least 1 month before screening visit. 3. Drug naïve status, or treatment with either monotherapy or a combination therapy of antihyperglycemic medication (stable ≥ 1 month at screening visit; not more than two combined treatments). 4. HbA1c 6.5 - 10.0 % (inclusive) at screening visit. 5. FPG ≤ 240 mg/dL (13.3 mmol/L) at screening visit. 6. eGFRMDRD ≥ 30 and < 60 mL/min/1.73m2 at screening visit. 7. UACR ≤ 3000 μg/mg at screening visit. 8. BMI from 25.0 kg/m2 (Asian patients: from 23.0 kg/m2) to 35.0 kg/m2. 9. Able and willing to give written informed consent and to comply with the requirements of the study. |
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E.4 | Principal exclusion criteria |
1. Current or previous treatment with a thiazolidinedione (e.g. medications containing pioglitazone or rosiglitazone, like Actos®, Avandia®, ActoplusMet™, Avandamet®, Avandaryl™), another PPAR γ agonist, or a dual PPAR α/γ agonist. 2. Current or previous treatment with insulin (with the exception of emergency cases in which insulin is given for < 7 consecutive days). 3. Treatment with fibrates in the 3 months preceding screening visit. 4. Treatment with statins in the last month before screening, except STABLE and not likely to require changes during the study. 5. Treatment with medications interfering with measurement of creatinine (e.g. cimetidine, trimethoprim, probencid, sulfonamides, procaine or thiazolesulfone). 6. Chronic therapy with NSAIDs (except prophylactic STABLE low dose aspirin in the last month before screening; dose not higher than 100 mg daily; paracetamol/acetaminophen is allowed). 7. Antihypertensive therapy in the last 3 months before screening, except STABLE, and not likely to require changes during the study. 8. Known diagnosis of renal disease other than diabetic nephropathy (e.g. polycystic kidney disease, kidney transplant, kidney cancer). 9. Systemic corticosteroid therapy within 3 months prior to screening visit. 10. Uncontrolled hypertension (SBP > 140 mmHg and/or DBP > 90 mmHg despite anti-hypertensive drug therapy; mean of two readings) at screening visit. 11. Impaired liver function (ALT or AST > 3 × ULN) at screening visit. 12. Creatine phosphokinase (CPK) elevated > 3 × ULN at screening visit. 13. History of drug induced myopathy. 14. Hemoglobin < 11 g/dL at screening visit [continuous erythropoiesis-stimulating agent (ESA) treatment is allowed]. 15. Congestive heart failure classified NYHA class II to IV at or prior to screening or randomization visit. 16. Peripheral edema above the ankle level at the screening or randomization visit. 17. Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening. 18. Vascular or cardiac surgery within 6 months prior to the screening visit. 19. Known macular edema at or prior to screening visit. 20. Planned major surgery during the course of the study. 21. Any serious illness (such as metastatic cancer, major active infection, severe psychiatric disorders) at screening visit. 22. Any other significant medical condition which would not allow participation in this study at the judgment of the investigator. 23. Positive pregnancy test, breastfeeding women and women not using an adequate method of contraception. 24. Participation in any clinical trial with an investigational drug within three months prior to the screening visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change from baseline in the eGFRMDRD at the end of the follow-up period (8 weeks after treatment end). |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
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.6.13.1 | Other scope of the trial description |
Renal Function, Efficacy, RCR (Roche Clinical Repository), Explonatory |
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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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
renal function study, with two treatment arms |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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The date of the last visit of the last patient (last patient last visit; LPLV) in the study. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 1 |