Aim: To investigate durability of efficacy and safety over 1 year of the sequence of liraglutide added to metformin followed by add-on insulin detemir if glycated hemoglobin (HbA1c) remains ≥7.0%.
Methods: Patients previously uncontrolled on metformin±sulfonylurea with HbA1c ≥7.0% after 12 weeks of adding liraglutide 1.8mg 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 HbA1c <7.0% continued 52 weeks' unchanged treatment (observational group; n=498).
Results: Run-in HbA1c 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 HbA1c <7.0% at 52 weeks (P<0.0001). Run-in weight loss (-3.5kg) was maintained in the RT (-0.05kg) and enhanced in the RC group (-1.02kg) after 52 weeks; ETD [95%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.
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