TY - BOOK AU - Aroda, Vanita R TI - Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).[Erratum appears in Diabetes Obes Metab. 2016 Sep;18(9):952; PMID: 27546838] SN - 1462-8902 PY - 2016/// KW - *Diabetes Mellitus, Type 2/dt [Drug Therapy] KW - *Hypoglycemic Agents/ad [Administration & Dosage] KW - *Insulin, Long-Acting/ad [Administration & Dosage] KW - *Liraglutide/ad [Administration & Dosage] KW - *Metformin/ad [Administration & Dosage] KW - Blood Glucose/me [Metabolism] KW - Double-Blind Method KW - Drug Therapy, Combination KW - Fasting/bl [Blood] KW - Female KW - Hemoglobin A, Glycosylated/me [Metabolism] KW - Humans KW - Hypoglycemia/ci [Chemically Induced] KW - Hypoglycemic Agents/ae [Adverse Effects] KW - Insulin, Long-Acting/ae [Adverse Effects] KW - Liraglutide/ae [Adverse Effects] KW - Male KW - Metformin/ae [Adverse Effects] KW - Middle Aged KW - Treatment Outcome KW - MedStar Health Research Institute KW - Journal Article N2 - AIM: To evaluate the efficacy and safety of adding insulin degludec (IDeg) to treatment in patients with type 2 diabetes receiving liraglutide and metformin and qualifying for treatment intensification because of inadequate glycaemic control; CONCLUSION: The addition of liraglutide and IDeg to patients sub-optimally treated with metformin and liraglutide and requiring treatment intensification was found to be effective and well-tolerated; Copyright � 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd; METHODS: In this 26-week, double-blind trial, patients who still had inadequate glycaemic control after a 15-week run-in period with initiation and dose escalation of liraglutide to 1.8mg in combination with metformin (>1500mg) were randomized to addition of once-daily IDeg ('IDeg add-on to liraglutide' arm; n=174) or placebo ('placebo add-on to liraglutide' arm; n=172), with dosing of both IDeg and placebo based on titration guidelines; RESULTS: At 26weeks, the mean change in glycated haemoglobin level was greater in the IDeg add-on to liraglutide arm (-1.04%) than in the placebo add-on to liraglutide arm (-0.16%; p<0.0001). Similarly, the mean fasting plasma glucose reduction was greater, and self-measured plasma glucose values were lower at all eight time points, with IDeg add-on versus placebo add-on (both p<0.0001). At 26weeks, the IDeg dose was 51U (0.54U/kg). During the run-in period with liraglutide, body weight decreased by ~3kg in both groups. After 26weeks, the mean change was +2.0kg (IDeg add-on to liraglutide) and -1.3kg (placebo add-on to liraglutide). Confirmed hypoglycaemia rates were low in both groups, although higher with IDeg than with placebo (0.57 vs. 0.12 episodes/patient-years of exposure; p=0.0002). Nocturnal confirmed hypoglycaemia was infrequent in both groups, with no episodes of severe hypoglycaemia, and no marked differences in adverse events with either treatment approach UR - https://dx.doi.org/10.1111/dom.12661 ER -