The REMOVAL study

• Research type

  Research Study

• Full title

  REducing with MetfOrmin Vascular Adverse Lesions in T1DM (The REMOVAL study)

• IRAS ID

  73420

• Contact name

  John Petrie

• Eudract number

  2011-000300-18

• Clinicaltrials.gov Identifier

  NCT01483560

• Research summary

  People with type 1 diabetes are at increased risk of heart attacks and strokes. Some of the risk factors for these serious complications are associated with obesity. Unfortunately, intensive insulin therapy used to try and control blood glucose can cause weight gain and aggravation of some heart disease risk factors.Our previous work shows that adding metformin in with insulin therapy in type 1 diabetes reduces the dose of insulin needed to achieve blood glucose control. This can reduce weight gain and improve some risk factors for heart attacks and strokes, including cholesterol.The first aim of the REMOVAL study is to test whether three years of metformin added to insulin therapy reduces a kind of thickening in the walls of blood vessels called ??intima-media thickness? (IMT). Carotid IMT is a good predictor of future heart attacks and strokes and is measured painlessly in the neck using ultrasound. Other main aims are to test metformin??s effects on the control of diabetes as well as in preventing other complications. This study aims to recruit 500 people with type 1 diabetes who are over 40 years of age, have an HbA1c of between 7 and 10% and are at increased risk of cardiovascular disease. Participants will initially enter a 3 month run-in phase. They will then be randomised to receive metformin or matching placebo, remaining on therapy for 3 years. During this time they will be invited to attend 11 study visits which will be timed to coincide with three-monthly appointments in routine care where possible. If we show that adding metformin tablets to insulin injections has beneficial effects, the REMOVAL study could lead to a change in treatment - and a reduced risk of complications - for many people with type 1 diabetes.

• REC name

  West of Scotland REC 1

• REC reference

  11/WS/0012

• Date of REC Opinion

  24 Aug 2011

• REC opinion

  Further Information Favourable Opinion