CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 57 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 850mgfrom 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/NCT01319994
NCT01319994Phase 3Completed

Prevention of Metabolic Complications of Glucocorticoid Excess - a Randomised, Doubleblind,Placebo Controlled Study

Barts & The London NHS Trust·interventional·Posted Mar 22, 2011·Updated Apr 12, 2019

In Brief

A Phase 3 clinical trial evaluating Metformin and Placebo for Iatrogenic Cushing Disease. Completed, enrolled 57 participants across 1 site.

Detailed Summary

According to current estimates, nearly 1% of the general population is treated with long-term glucocorticoids. Chronic hypercortisolism leads to a phenotype that resembles the metabolic syndrome. The investigators have shown that inhibition of adenosine-monophosphate-activated protein kinase (AMPK) activity in adipose tissue plays a role in corticosteroid-mediated insulin resistance. Metformin, one of the mainstay therapies for type 2 diabetes, is a known activator of AMPK, which mediates its beneficial effects on glucose and lipid metabolism. The investigators have shown in an animal model that metformin - via altering AMPK activity - prevents the development of the metabolic complications of glucocorticoid excess, and the investigators wish to confirm this in a human study. The aim of this prospective, randomised, double-blind, placebo-controlled study is to investigate the effect of metformin treatment on metabolic parameters in patients on long-term high-dose glucocorticoids. The study is part of the investigators translational project and could rapidly lead to immediate patient benefit, improving quality of life and reducing health care costs for the NHS.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.3 years ago

Interventions

Metformindrug

Metformin 850mg TDS (12 weeks)

Placebodrug

Placebo 850mg TDS (12 weeks)