Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos®

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 ? agonist, or a dual PPAR a/? 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 <br>stage 3), in comparison with Actos® treatment.;Secondary Objective: - 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).<br>- To determine the effects of 150 µg aleglitazar treatment on lipid profile.;Primary end point(s): Percent change from baseline in the eGFRMDRD at the end of the follow-up period (8 weeks after treatment end).

Secondary Outcome Measures

Name	Time	Method

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