Dettagli per singolo studio

DEC-NET Serial number GB504

Published online	11/10/2005 14.06.00
Last updated	17/10/2005 13.59.21


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	07/2004 50
Major Disease (ICD9 class)	DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE I
Experimental drug
METFORMIN Treatment regimen (dosage and duration) 1275mg for 6 months twice a day (please note metaformin is combined with flutamide so that only one tablet is given)
FLUTAMIDE Treatment regimen (dosage and duration) 62.5 mg for six months twice a day (please note flutamide is combined with metformin so that only one tablet is given)
Gender
Age (range)	12-21 years
Eligibility criteria
Inclusion criteria
Type 1 diabetes mellitus for greater than 2 years and 2 years postmenarche
Exclusion criteria
Pregnancy, on the oral contraceptive pill unless willing to come off for 6 months, HbA1c>12%, untreated hypothyroidism or coeliac disease, other chronic illness, emotional/social instability, drug or alcohol abuse
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
It is hypothesised that ovarian hyperandrogenism may be more common in young women with Type 1 Diabetes Mellitus; that the severity of presentaion may vary between populations because of background variability in common genetic polymorphism at the androgen receptor; that women with Type 1 Diabetes mellitus may benefit from combined treatment with metformin and flutamide.
Primary outcomes
Changes in Free Androgen Index Changes in ovulation rates Changes in truncal/abdominal fat mass
Secondary outcomes
HbA1C improvement Daily insulin dose decrease Changes in urine ACR
Summary of study design, objectives, and ongoing research findings
Females with diabetes are at higher risk during puberty of developing complications related to diabetes than male. These factors may be linked to abnormally high blood levels of androgen hormones, produced by cysts in the ovaries in response to the high levels of blood insulin injected subcutaneously as part of routine diabetic care. 50% of diabetic women show such features, and this may vary according to genetic background. In non-diabetic women, metformin (an insulin sensitiser) together with low dose flutamide (a weak anti-androgen) reduce androgen levels and improve the way the body utilises insulin. Consequences of these changes are reduced body fat, improved ovulation rates and a lowering of markers of future cardiovascular problems, such as lipids. 150 young adult diabetic women from centres in 3 countries will be screened for these features with blood tests, ovarian ultrasound scan and genetic analysis. The relationship of these features to each other and to genetic variation will be analysed. 50 subjects with evidence of high blood androgens levels and reduced ovulation rates will be recrited to receive either Metformin and Flutamide or placebo for 6 months, in a double-blind randomised trial. At 3 monthly intervals each subject will have an assessment of the features described above. Regular insulin therapy will be continued throughout this time. Markers of successful therapy will be improved glucose control, and markers of future complications related to diabetes.