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This study examines the effect of the drug Allopurinol, compared with placebo (lactose), on oxidative stress and mitochondrial changes in the skeletal muscle of patients with type 2 diabetes. Patients who have had type 2 diabetes for at least a year, are on oral anti-diabetic medication, and meet certain laboratory criteria may take part. The study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * BMI from 25 to 40 kg/m² * Type 2 diabetes known for over one year but less than 10 years, treated with Oral anti-diabetic drugs or a Glucagon-like peptide-1 (GLP1-analog) * well controlled hypertension (untreated or currently treated) with a systolic blood pressure of 95 to 140 mmHg and diastolic blood pressure of 45 to 90 mmHg and heart frequency of 40 to 100 per minute * Recent HbA1c \< 9 % * Uricemia \> 300 µmol/l * For women : Menopausal or contraception * Renal function as defined by glomerular filtration rate (GFR) ≥ 80 mL/min/1.73 m2 Exclusion Criteria: * Tobacco ( more than 5 cigarettes) * Excessive drinking * Known pathology * Hypersensitivity to allopurinol * Treatment by anticoagulants, allopurinol, regular steroids or Nonsteroidal anti-inflammatory drug (NSAID), fibrate or insulin