REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

Summary

The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Metformin

3 years treatment duration

DRUG

Placebo

3 years duration

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• University of Dundee

  collaborator OTHER

• Merck Serono S.A., Geneva

  collaborator INDUSTRY

• Itamar-Medical, Israel

  collaborator INDUSTRY

• University of Western Ontario, Canada

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• University of Glasgow

  lead OTHER

Principal Investigators

• John Petrie, Prof · University of Glasgow

• Helen Colhoun, Prof · University of Dundee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2017-03-19

Completion

2017-04-18

Countries

• Australia
• Canada
• Denmark
• Netherlands
• United Kingdom

Study Locations