Lundby Christensen L, Almdal T, Boesgaard T, Breum L, Dunn E, Gade-Rasmussen B, Gluud C, Hedetoft C, Jarloev A, Jensen T, Krarup T, Johansen LB, Lund SS, Madsbad S, Mathiesen E, Moelvig J, Nielsen F, Perrild H, Pedersen O, Roeder M, Sneppen SB, Snorgaard O, Tarnow L, Thorsteinsson B, Vaag A, Vestergaard H, Wetterslev J, Wiinberg N, CIMT Trial Group

Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

Diabetes Obes Metab 2009;11:315–22

Diabetes mellitus

To evaluate the effects on carotid intima-media thickness of metformin vs placebo in combination with one of three insulin analogue regimens in patients with type 2 diabetes

Randomised, open (insulin), double-blind and placebo-controlled (metformin), 2 × 3 factorial

18 months

Aim 950 patients, aged > 30 years, with type 2 diabetes, body mass index 25–40 kg/m², HbA_1c ≥ 7.5%, taking oral hypoglycaemic agents or insulin

Metformin, 1000 mg bid, or placebo, plus insulin detemir once daily, insulin aspart 1–3 times daily, or insulin detemir once daily plus insulin aspart tid

ASA in all patients. Antihypertensive agents and lipid-lowering agents at the discretion of the physician

Not yet available