MedStar Authors catalog › Details for: 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]
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]
Citation: Diabetes, Obesity & Metabolism. 18(7):663-70, 2016 Jul.Journal: Diabetes, obesity & metabolism.Published: 2016ISSN: 1462-8902.Full author list: Aroda VR; Bailey TS; Cariou B; Kumar S; Leiter LA; Raskin P; Zacho J; Andersen TH; Philis-Tsimikas A.UI/PMID: 26990378.Subject(s): Blood Glucose/me [Metabolism] | *Diabetes Mellitus, Type 2/dt [Drug Therapy] | Double-Blind Method | Drug Therapy, Combination | Fasting/bl [Blood] | Female | Hemoglobin A, Glycosylated/me [Metabolism] | Humans | Hypoglycemia/ci [Chemically Induced] | *Hypoglycemic Agents/ad [Administration & Dosage] | Hypoglycemic Agents/ae [Adverse Effects] | *Insulin, Long-Acting/ad [Administration & Dosage] | Insulin, Long-Acting/ae [Adverse Effects] | *Liraglutide/ad [Administration & Dosage] | Liraglutide/ae [Adverse Effects] | Male | *Metformin/ad [Administration & Dosage] | Metformin/ae [Adverse Effects] | Middle Aged | Treatment OutcomeInstitution(s): MedStar Health Research InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1111/dom.12661 (Click here)Abbreviated citation: Diabetes Obes Metab. 18(7):663-70, 2016 Jul.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: Copyright � 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.