One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target

Aim: To investigate durability of efficacy and safety over I year of the sequence of liraglutide added to metformin followed by add-on insulin detemir if glycated hemoglobin (HbA(1c)) remains 7.0%. Methods: Patients previously uncontrolled on metformin sulfonylurea with HbA(1c) >= 7.0% after 12 weeks of adding liraglutide 1.8 mg to metformin (run-in; sulfonylurea discontinued) were randomized 1:1 to 52 weeks' open-label add-on detemir (randomized treatment [RT] group; n = 162) or continuation without detemir (randomized control [RC] group; n = 161). Patients with HbA(1c) <7.0% continued 52 weeks' unchanged treatment (observational group; n = 498). Results: Run-in HbA(1c) improvement from 8.3% to 7.6% (-0.6%) was further enhanced in the RT group (-0.50%) and maintained in the RC group (+0.01%) over 52 weeks; estimated treatment difference (ETD)[95%CI]: -0.51 [-0.70; 0.31]; P < 0.0001. More RT (52%) than RC patients (22%) achieved HbA(1c), <7.0% at 52 weeks (P < 0.0001). Run-in weight loss (-3.5 kg) was maintained in the RT (-0.05 kg) and enhanced in the RC group (-1.02 kg) after 52 weeks; ETD 195%CI]: 0.97 [0.04;1.91]; P = 0.04. No major hypoglycemia occurred; minor hypoglycemia rates were low across groups (0.034-0.228 events/patient-year). Conclusions: Supplementing metformin + liraglutide with detemir for 52 weeks improved glycemic control with sustained weight loss and low hypoglycemia rate. (C) 2013 The Authors. Published by Elsevier Inc. All rights reserved.