Glucophage-SR an adjunct to insulin in non-overweight type-1 Diabetics

• Research type

  Research Study

• Full title

  Effectiveness of Glucophage® SR as an adjunct to insulin in improving glycaemic control, without increasing the episodes of hypoglycaemia, in non-overweight patients with type-1 Diabetes.

• IRAS ID

  63788

• Contact name

  Atir Khan

• Sponsor organisation

  Hywel Dda Health Board

• Eudract number

  2010-022809-18

• ISRCTN Number

  85760737

• Research summary

  The purpose of the study is to study the effectiveness of a tablet Glucophage© SR (commonly known by the name metformin), when added with insulin, in improving blood glucose control without increasing the chances of low blood sugar levels (hypoglycemia episodes) in non-overweight patients with insulin treated (or type-1) Diabetes. Diabetes treatment aims to keep blood glucose levels under control in order to prevent short-term complications and reduce the risk of long-term complications. Diabetes care is complex and it means that patients need to keep their blood sugar levels low (4-7 mmol/L) by being careful with their diet and by exercising. In reality, achieving tight blood sugar levels is often difficult and frequently results in episodes of low blood sugar levels known as hypoglycemia. Hypoglycemia in diabetes is a fearsome complication and must be avoided. Past research has shown that it (hypoglycemia) results in loss of patient??s confidence in achieving good control of their blood glucose levels and also affects the other family members (for example parents and spouses). It is also a common observation in Diabetic clinics that the patients often do not achieve their target blood glucose levels due to fear of hypoglycemia and as a result the glycemic control remains poor which can result in development of Diabetes related complications. In this study we aim to improve the glycemic control, without causing an increase in hypoglycemic episodes, in this particular group of patients by adding Glucophage-SR to insulin.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/35

• Date of REC Opinion

  25 Oct 2010

• REC opinion

  Further Information Favourable Opinion