Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

Phase 4

• Conditions: Diabetes mellitus

• Registration Number: JPRN-UMIN000012430
• Lead Sponsor: Graduate School of Medicine, the University of Tokyo

Brief Summary

J-PREDICT ADA 73rd Scientific Sessions (2013) Session: Late Breaking Abstracts Abstract Number: 61-LB Title: Pitavastatin for the Delay or Prevention of Diabetes Development in Individuals with Impaired Glucose Tolerance Abstract: Of 8,472 patients who underwent screening, 1,269 individuals with impaired glucose tolerance (IGT) were randomized to either the pitavastatin group (lifestyle modification and pitavastatin [1-2 mg/day]) or the control group (lifestyle modification only). The diabetes incidence rates for the pitavastatin and control groups were 163 and 186 cases per 1,000 person-years, respectively; the hazard ratio for progression from IGT to diabetes in the pitavastatin group was 0.82 (95% CI: 0.68-0.99; P = 0.041). Even in any subgroups, pitavastatin did not accelerate the incidence, unlike the effects of statins in previous reports. Pitavastatin in combination with lifestyle modification was associated with a lower incidence of diabetes than was lifestyle modification alone in Japanese patients with IGT. Statins are now used with the understanding that a slightly increased risk of diabetes is outweighed by cardiovascular benefits of the drugs. However, based on our results, it may be necessary to reconsider whether all statins really increase the risk of developing diabetes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-03-31
• Study Start: 2013-11-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1240

Inclusion Criteria

Not provided

Exclusion Criteria

-History of diabetes (except gestational diabetes) -Fasting plasma glucose >= 126 mg/dl, and/or 2-h plasma glucose >= 200 mg/dl -HbA1c >= 6.5 % -Diabetic retinopathy -Receiving with hormone replacement therapy -Pancreatic diseases (e.g.pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases (e.g. Cushing's syndrome, acromegaly, pheochromocytome, aldosteronism, hyperthyroidism) -Receiving statins, fibrates or anion exchange resins -Cancer or suspected cancer -History of gastrectomy -History of myocardial infarction, angina, or heart failure (NYHA Class >= III) -Severe hypertension (SBP >= 180 mmHg or DB` >= 110 mmHg) -Renal disease, including serum creatinine >= 2.0 mg/dl -Hepatic disease, including transaminase (ALT or AST) >= 2 times the upper limit of normal -Women hoping to become pregnant during the intended stury period -Contraindication or relative contraindication of Livalo Tab (pitavastatin calcium) a) History of hypersensitivity to any of the ingredients of the product b) Severe hepatic disorder or biliary atresia c) Receiving cyclosporine d) Pregnant women, women suspected of being pregnant, or lactating women e) Patients receiving fibrates who also have laboratory evidence of abnormal renal function -Familial hypercholesterolemia -Drug abuse, alcoholism -Individuals who are ineligible in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified