Arteriosclerosis, Atherosclerosis, Type 2 Diabetes
Conditions
Keywords
carotid, intima, media, thickness, insulin, metformin
Brief summary
Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.
Interventions
DRUGmetformin
metformin tablets 2 g x 2
DRUGinsulin detemir
insulin as requested
DRUGinsulin aspart + insulin aspart protamin
insulin as requested
DRUGInsulin aspart
insulin as requested
Sponsors
Hvidovre University Hospital
Hillerod Hospital, Denmark
Frederiksberg University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Bispebjerg Hospital
Herlev Hospital
Zealand University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Novo Nordisk A/S
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females over 30 years of age * Type 2 diabetes * Body mass index (BMI): 25.0-39.9 kg/m2 * HbA1c above 7.5 % * Antidiabetic tablet-treatment during 1 year minimum AND / OR * Insulin treatment during a minimum of 3 months * Negative pregnancy test * Signed, informed consent
Exclusion criteria
* MI, coronary revascularization, TCI,or apoplexy within the last 3 months * TCI with verified stenosis of above 70% * Heart failure (NYHA class III or IV) * Former cancer patient, unless disease-free period of more than 5 years * estimated creatinine clearance \< 60 ml/min Liver disease * Alcohol abuse * Drug abuse * Retinopathy with on-going laser treatment at start of study * Other acute or chronic serious disease leading to hypoxia * Pregnant or breastfeeding women * Women of child-bearing potential, not using contraceptives * Allergy to medication used in the study * Incapable of understanding the nature of the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid intima media thickness | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| adverse events | 18 months |
Countries
Denmark
Outcome results
None listed