CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 25mgfrom 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/NCT01053078
NCT01053078Phase 2Completed

Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus

University of Minnesota·interventional·Posted Jan 21, 2010·Updated Feb 5, 2020

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Placebo for Type 1 Diabetes and Hypoglycemia Unawareness. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death. Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia. The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2010
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.4 years ago

Interventions

Naltrexonedrug

1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days

Placeboother

1 month treatment; placebo tablet once daily for 28 days