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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
415
Rigshospitalet
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Frederiksberg Hospital
Frederiksberg, Denmark
Gentofte Sygehus
Gentofte Municipality, Denmark
Carotid intima media thickness
Time frame: 18 months
adverse events
Time frame: 18 months
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insulin as requested
Steno Diabetes Center
Gentofte Municipality, Denmark
Herlev Hospital
Herlev, Denmark
Hillerod Sygehus
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Køge Sygehus
Køge, Denmark