CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Pravastatin +2 moredrug
Likely dose
Pravastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02754739
NCT02754739Phase 4Completed

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

Samsung Medical Center·interventional·Posted Apr 28, 2016·Updated Sep 13, 2018

In Brief

A Phase 4 clinical trial evaluating Pravastatin, Placebo (for Pravastatin), and 1 other intervention for Diabetes Mellitus and Prediabetic State. Completed, enrolled 44 participants across 1 site.

Detailed Summary

An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin may have different effect on the development of incident diabetes. In the West of Scotland Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. In this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartApr 15, 2014
Primary CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Pravastatindrug

Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist

Placebo (for Pravastatin)drug

Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist

Nutritional education onlybehavioral

Only nutritional education by a nutritionist