Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Effect of Metformin On Glycaemic Control and Non-Glycaemic Cardiovascular Risk-Factors in Patients With Type-1 Diabetes, With Long-Standing Inadequate Glycaemic Control by Insulin and Diet
Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in
the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important
risk-factor for development of these late-diabetic complications. The Diabetes Control and
Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the
development and progression of these late-diabetic complications. Until now treatment with
insulin- and diet-therapy has been the only treatment-modalities available to improve the
glycaemic control in patients with type-1-diabetes. A substantial number of these patients
still have long-standing poor glycaemic control despite intensive treatment with insulin-
and diet-therapy.
The antidiabetic drug metformin has shown to be able to improve the glycaemic control in
combination with insulin and furthermore reduce both mortality and the risk of developing
cardiovascular disease in patients with type-2-diabetes.
Only few small studies have investigated the effect of treatment with metformin in patients
with type-1-diabetes. These studies have suggested a positive effect of metformin in these
patients too.
Method:
100 patients with type-1-diabetes with persistent poor glycaemic control i.e. HbA1c > 8.5%
during the last 12 months are eligible. Patients are treated for one month with placebo.
Hereafter half of the patients will be treated with metformin and the other half continues
with placebo for 12 months both as add-on therapy. All patients are continuing ongoing
treatment with insulin throughout the study. Before and after the start of treatment with
metformin the effect on glycaemic control and other known risk-factors for development of
cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion,
endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.
This study will show if treatment with metformin can improve the glycaemic control and
hereby the prognosis of patients with type-1-diabetes with persistent poor glycaemic control
despite intensive treatment with insulin- and diet-therapy. This group of patients suffers
the highest risk of developing late-diabetic complications with reduced quality of life and
life-expectancy as a consequence.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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