CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 10 mgfrom 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/NCT00529191
NCT00529191Phase 2Completed
CompareCT.gov

Phase II, Double Blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin in Subjects With Newly Diagnosed Type 1 Diabetes Mellitus.

Children's Hospital of Philadelphia·interventional·Posted Sep 14, 2007·Updated Mar 13, 2017

In Brief

A Phase 2 clinical trial evaluating Atorvastatin and Placebo for Type 1 Diabetes. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsFDA Office of Orphan Products Development, Medical University of South Carolina

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2011
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.8 years ago

Interventions

Atorvastatindrug

Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months

Placeboother

One out of three subjects will receive a placebo.