Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-022-10
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

• Age> 18 years in the selection visit.
• Men and women diagnosed with DM2 based on the WHO criteria for at least 1 month before the selection visit.
• 3 Never before receiving the drug or being treated with either monotherapy or a combination therapy of antihyperglycemic drugs (stably for> 1 month in the selection visit, no more than two combined treatments).
• HbA1c of 6.5 -10.0% (inclusive) in the selection visit.
• Fasting plasma glucose (fasting plasma glucose. FPG) <240 mg / dl (13.3 mmol / L) at the selection visit.
• cGFRmdrd> 30 and <60 ml / min / 1.73 m2 in the selection visit
• UACR <3000 ug / mg at the visit of choice.
• A body mass index from 25.0 kg / m2 (Asian patients; from 23.0 kg / m2) to 35.0 kg / m2.
• Be able and willing to provide written informed consent and comply with the requirements of the study protocol

Exclusion Criteria

• Previous or current treatment with a thiazolidinedione (eg, medications containing pioglitazone or rosiglitazone such as Actos®, Avandia®, ActoplusMet Avaudamet® or Avandary, another receptor agonist activated by peroxisomal proliferators (peroxisome proliferatoractivated receptor, PPAR) or a PPAR a / y dual agonist,
• Previous or current insulin treatment (with the exception of emergency cases in which insulin is administered for <7 consecutive days),
• Treatment with fibrates in the 3 months prior to the selection visit.
• Treatment with statins in the last month before selection, except in a STABLE manner and that requires unlikely changes during the study.
• Treatment with medications that interfere with the measurement of creatinine (eg, cimetidine, trimethoprim, probenecid, siilfonaraides, procaine or lysoolsulfones).
• Chronic therapy with NSAID (except for prophylactic low-dose aspirin in a stable manner in the last month before selection: dose not exceeding 100 mg daily; paracetamol or acetaminophen is allowed).
• Antihypertensive therapy in the last 3 months before the selection, except in a STABLE manner and which unlikely to require changes during the study.
• Known diagnosis of kidney disease other than diabetic nephropathy (eg, polycystic kidney disease, kidney transplant, kidney cancer).
• Systemic corticosteroid therapy within 3 months prior to the selection visit,
• Uncontrolled hypertension (PAS> 140 mm Hg and / or PAD> 90 mm Hg despite therapy with an antihypertensive drug; mean of two measurements) at the selection visit.
• 11. Impaired liver function (TGP or TGO> 3 times above the upper limit of the normal range [upper limit of normal, ULN]) at the selection visit.
• Creatine phosphokinase (creatine phosphokinase, CPK)> 3 times on the ULN in the selection visit.
• History of drug-induced myopathy.
• Hemoglobin <11 g / dl at the selection visit [continuous treatment with erythropoiesis stimulating agents] is allowed.
• Congestive heart failure classified as functional class II to IV according to the criteria of the New York Heart Association (NYHA) on or before the selection or randomization visit.
• Peripheral edema above the ankle level in the selection or randomization visit.
• Myocardial infarction, acute coronary syndrome or transient ischemic stroke / stroke within 6 months prior to selection.
• Vascular or cardiac surgery within 6 months prior to the selection visit.
• Known macular edema on or before the selection visit.
• Major surgery scheduled to be performed during the course of the study.
• Any serious illness (such as metastatic cancer. Major active infection, severe psychiatric disorder) at the screening visit.
• Any other significant medical condition that does not allow patient participation in this investigative study.
• Positive pregnancy test, lactating women and those who are not using an appropriate contraceptive method.
• Participation in any clinical study with an investigational drug within three months prior to the selection view.

Study & Design

• Study Type: Interventional
• Study Design: Not specified