Stewart B Harris1, Olubukola Ajala2, Basel Bari3, Joanne Liutkus4, Jina Hahn5, Oliver Martyn6, Deborah Zwicker7. 1. Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, WCPHFM, 1465 Richmond St, London, ON, N6G 2M1, Canada. stewart.harris@schulich.uwo.ca. 2. LMC Healthcare, Alberta, Canada. 3. Markham Health Plex, Markham, ON, Canada. 4. Joanne F. Liutkus Medicine Professional Corporation, Cambridge, ON, Canada. 5. Novo Nordisk Canada Inc., Mississauga, ON, Canada. 6. Novo Nordisk A/S, Søborg, Denmark. 7. Division of Endocrinology and Metabolism, Department of Medicine, Dalhousie University, Halifax, Canada.
Abstract
INTRODUCTION: The aim of the study was to examine glycaemic control and safety of insulin degludec (degludec) in patients with either type 1 diabetes (T1D) or type 2 diabetes (T2D) under routine care settings in Canada. METHODS: Data were extracted from medical records of adults with T1D or T2D who switched to degludec (± prandial insulin) from another basal insulin (± prandial insulin) ≥ 6 months prior to data collection. The primary endpoint was change in glycated haemoglobin (HbA1c) at 6 ± 3 months after degludec initiation. Secondary endpoints included change in hypoglycaemia rate in the 6 months before versus the 6 months after switching, and change in mean total daily insulin dose. RESULTS: Of 667 patients assessed for eligibility, 626 were included. After 6 ± 3 months, HbA1c decreased from baseline in patients with T1D (- 0.3% [- 0.42, - 0.14]95% CI; p < 0.001) and in patients with T2D (- 0.4% [- 0.55, - 0.30]95% CI; p < 0.001). In patients with T1D, there were significant reductions in the rates of overall (rate ratio [RR] 0.70), non-severe (RR 0.69), non-severe nocturnal (RR 0.36), and severe nocturnal hypoglycaemia (RR 0.12; all p ≤ 0.004). In patients with T2D there was a significant reduction in non-severe nocturnal hypoglycaemia (RR 0.22; p < 0.001). Mean daily basal insulin dose decreased in patients with T1D (- 1.6 units [- 2.8, - 0.4]95% CI; p = 0.008); there was no significant change in patients with T2D (- 0.6 units [- 2.7, 1.4]95% CI; p = 0.543). CONCLUSION: In routine clinical practice, improved glycaemic control was observed in patients with T1D or T2D switching to insulin degludec from other basal insulins, with either improvement or no change in hypoglycaemia rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT03674866.
INTRODUCTION: The aim of the study was to examine glycaemic control and safety of insulindegludec (degludec) in patients with either type 1 diabetes (T1D) or type 2 diabetes (T2D) under routine care settings in Canada. METHODS: Data were extracted from medical records of adults with T1D or T2D who switched to degludec (± prandial insulin) from another basal insulin (± prandial insulin) ≥ 6 months prior to data collection. The primary endpoint was change in glycated haemoglobin (HbA1c) at 6 ± 3 months after degludec initiation. Secondary endpoints included change in hypoglycaemia rate in the 6 months before versus the 6 months after switching, and change in mean total daily insulin dose. RESULTS: Of 667 patients assessed for eligibility, 626 were included. After 6 ± 3 months, HbA1c decreased from baseline in patients with T1D (- 0.3% [- 0.42, - 0.14]95% CI; p < 0.001) and in patients with T2D (- 0.4% [- 0.55, - 0.30]95% CI; p < 0.001). In patients with T1D, there were significant reductions in the rates of overall (rate ratio [RR] 0.70), non-severe (RR 0.69), non-severe nocturnal (RR 0.36), and severe nocturnal hypoglycaemia (RR 0.12; all p ≤ 0.004). In patients with T2D there was a significant reduction in non-severe nocturnal hypoglycaemia (RR 0.22; p < 0.001). Mean daily basal insulin dose decreased in patients with T1D (- 1.6 units [- 2.8, - 0.4]95% CI; p = 0.008); there was no significant change in patients with T2D (- 0.6 units [- 2.7, 1.4]95% CI; p = 0.543). CONCLUSION: In routine clinical practice, improved glycaemic control was observed in patients with T1D or T2D switching to insulindegludec from other basal insulins, with either improvement or no change in hypoglycaemia rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT03674866.
Entities:
Keywords:
Canada; Glycaemia; Glycaemic control; Hypoglycaemia; Insulin degludec; Real-world; Type 1 diabetes; Type 2 diabetes
Authors: Venu Menon; A Michael Lincoff; Stephen J Nicholls; Susan Jasper; Kathy Wolski; Darren K McGuire; Cyrus R Mehta; Julio Rosenstock; Claudia Lopez; John Marcinak; Charlie Cao; Steven E Nissen Journal: Diabetes Care Date: 2018-12 Impact factor: 19.112