Title: REMOVAL study: REducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes
Funder: Juvenile Diabetes Research Foundation

Abstract: The objective of REMOVAL is to test whether metformin tablets added in with insulin injections in type 1 diabetes can prevent the early blood vessel complications which lead to heart attacks and strokes, while helping to improve blood glucose and cholesterol, stabilise weight, and prevent other complications. Heart attacks and strokes are the most common cause of death. They affect people with type 1 diabetes more often and at a younger age. The risk starts in young adulthood, although 95% of events affect those aged 40 years and over. Given these statistics, it is remarkable that so few clinical trials have been conducted targeting the early changes in blood vessels which lead to heart attacks and strokes in type 1 diabetes. The Diabetes Control and Complications Trial showed that good blood glucose control can reduce the risk, but this remains a significant challenge for many individuals. For example, simply increasing insulin can lead to more hypos. It can also lead to increased weight, higher blood pressure, and increased levels of cholesterol-like substances in the blood. Adding in metformin with insulin could help prevent heart attacks and strokes in type 1 diabetes. Our previous work shows that less insulin is needed to achieve blood glucose control when metformin tablets are taken, and that weight is less likely to go up. Cholesterol is often reduced. Some doctors already prescribe metformin for overweight people with type 1 diabetes but we believe more information is required before this treatment can be recommended widely. For example, no studies conducted to date have looked at metformins effects on risk factors for heart attacks and strokes in type 1 diabetes and few have aimed to do this while targeting improved glucose control. As an international team of investigators with expertise in the use of metformin, we have designed the REMOVAL study to address this gap in the scientific evidence. 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. Heart attacks and strokes are the most common cause of death. They affect people with type 1 diabetes more often and at a younger age. The risk starts in young adulthood, although 95% of events affect those aged 40 years and over. Given these statistics, it is remarkable that so few clinical trials have been conducted targeting the early changes in blood vessels which lead to heart attacks and strokes in type 1 diabetes. Adding in metformin with insulin could help prevent heart attacks and strokes in type 1 diabetes. Our previous work shows that less insulin is needed to achieve blood glucose control when metformin tablets are taken, and that weight is less likely to go up. Cholesterol is often reduced. Some doctors already prescribe metformin for overweight people with type 1 diabetes but we believe more information is required before this treatment can be recommended widely.


Research activity codes: 5.1 PHARMACEUTICALS
Health categories: METABOLIC AND ENDOCRINE