Diabetes Mellitus Type 2, Kidney Disease, Chronic
Conditions
Brief summary
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
Interventions
DRUGAleglitazar
Aleglitazar 150 mcg oral doses, once a day for approximately 3 years
DRUGPlacebo
Matching placebo to aleglitazar, once a day for approximately 3 years
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \>= 18 years of age at screening * Diagnosis of diabetes mellitus Type 2 * Glycosylated hemoglobin A1C (HbA1C) \< 10% at screening * Estimated glomerular filtration rate (eGFR) \>=30 and \< 60 mL/min/1.73 m2 * Urinary albumin-to-creatinine ratio (UACR) \>=500 and \< 5000 mg/g * Treatment with either angiotensin converting enzyme inhibitor or angiotensin II receptor blocker for at least three months prior to screening * Women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study
Exclusion criteria
* Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening * Prior intolerance to a TDZ or fibrate * Previous participation in a trial with aleglitazar * Diagnosis or history of other types of diabetes * Diagnosis or history of acute metabolic diabetic complications within the past 6 months * Known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease * Diagnosed acute kidney injury or dialysis within 12 weeks prior to screening * Poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at baseline) * Known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma * History of myocardial infarction or stroke in the past 12 weeks prior to screening * Symptomatic congestive heart failure NYHA class II-IV at baseline or heart failure leading to hospitalization within the 12 months prior to screening * Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years * Inadequate liver and hematological function * Chronic treatment with immunosuppressive therapy * Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death | Approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) | Approximately 5 years |
| Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke) | Approximately 5 years |
| Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality | Approximately 5 years |
Outcome results
None listed