LAUSR

Insulin degludec (degludec) is a basal insulin with an ultra-long duration of action and low day-to-day variability in the glucose-lowering effect. The aim of this non-interventional, multicentric, prospective, post-authorization safety study (PASS) was to evaluate the long-term (1 year) safety and effectiveness of insulin degludec in patients with diabetes mellitus (DM) requiring insulin therapy on routine clinical practice conditions, as required by the Indian regulatory authority. Eligible patients who were started with degludec treatment as per the physician’s discretion were followed up and data was collected at baseline (BL), 3, 6 and 12 months in the time periods after degludec initiation. Values are expressed as mean (SD). A total of 1057 adult patients with DM (5 with T1D and 1052 with T2D) were included. In total, 59.6% were male, mean age 55.9 (11.5) years, duration of diabetes 11.4 (7.6) years, body weight 71.6 (13.7) kg and HbA1c 9.6 (1.9)%]. Majority of the subjects (81.83%) were insulin-naive at BL. At 12 months follow-up, 44 adverse events (AEs) were reported in 2.6% of the subjects and 2 AEs were serious. HbA1c decreased significantly compared to BL by 1.8% (1.68) (p In conclusion, this PASS confirms the long-term safety of treatment with degludec with improvement in glycemic control and low risk of hypoglycemia in patients with T2D on routine clinical care. Disclosure J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker9s Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker9s Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker9s Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker9s Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker9s Bureau; Self; AstraZeneca. L. Murthy: None. B.D. Saboo: None. S. Yalamanchi: None. B. Ramanathan: Speaker9s Bureau; Self; Novo Nordisk India Private Limited, Eli Lilly and Company, Boehringer Ingelheim, Sanofi-Aventis, Zydus Pharmaceuticals, USV Private Limited, DR.REDDY9S LABORATORIES, AstraZeneca, Biocon, Johnson and Johnson, MSD, Novartis, Glenmark, Abbott. S. Gupta: Speaker9s Bureau; Self; Novo Nordisk India Private Limited, MSD, AstraZeneca, Novartis, USV Private Limited, Abbott. S. Chatterjee: None. M. Revanna: Employee; Self; Novo Nordisk India Private Limited. H. Kasetty: Employee; Self; Novo Nordisk India Private Limited.