Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118937
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2005-07-01
Brief Title:
Effect of Metformin in Patients With Type-1 Diabetes With Inadequate Glycaemic Control by Insulin and Diet
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie HbA1c 85 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
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 ie HbA1c 85 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None