None listed
Conditions
Brief summary
Metformin is a first line drug treatment in overweight patients with type 2 diabetes mellitus and has been used for decades in the treatment of these patients. People with type 2 diabetes mellitus can produce some insulin (which is different from patients with type 1 diabetes who need insulin to survive), but the body tissues are resistant to insulin leading to high blood glucose (sugar) because glucose in the blood is not absorbed. Many people with type 1 diabetes mellitus also have insulin resistance and in addition the insulin therapy that they need to survive often leads to weight gain. Metformin works by decreasing blood glucose (sugar) levels by increasing insulin sensitivity in muscle cells, decreasing glucose production in the liver and delaying glucose uptake from the guts. Metformin also have beneficial effects on weight management and risk of stroke and heart attacks in people type 2 diabetes mellitus. Some studies have found evidence that metformin added to insulin therapy in type 1 diabetes mellitus leads to weight loss and reduced requirement for insulin, but the results are not conclusive. We are conducting this trial to investigate if metformin is useful as an addition to insulin therapy to lose weight, improve glucose control, reduce insulin dose requirement and improve blood lipids in people with type 1 diabetes mellitus.
Interventions
Metformin dose will start at one tablet a day (500 mg extended release) and be increased to a maximum of 2,000 mg at the end of one month. The dose will be increased as tolerated by the patient. If after one week one tablet at night has been tolerated (i.e. no diarrhoea or indigestion) then the dose will be increased to two tablets at night. After a further week if the study medication is not causing any problems, a morning dose will be introduced. The next week another tablet in the morning wil
Metformin dose will start at one tablet a day (500 mg extended release) and be increased to a maximum of 2,000 mg at the end of one month. The dose will be increased as tolerated by the patient. If after one week one tablet at night has been tolerated (i.e. no diarrhoea or indigestion) then the dose will be increased to two tablets at night. After a further week if the study medication is not causing any problems, a morning dose will be introduced. The next week another tablet in the morning will be added, so that at the end of the month the patients will be taking two tablets twice per day. Duration of treatment is one year.
Sponsors
Professor Peter Clifton
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes mellitus for at least 2 years diagnosed before the age of 25 years, BMI>=27 kg/m2, HbA1c>= 7.5%, age 18-65 years, CrCl >= 45 ml/min
Exclusion criteria
Contraindications to metformin (such as hepatic failure, renal failure, lactation), hypoglycemic unawareness, pregnancy, history of drug or alcohol abuse, alcoholism, inability to comply, serious co-morbidities.
Outcome results
None listed