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-naïve 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<0.0001). Daily degludec dose increased from a starting dose of 14.8 (8.0) U to 18.01 (9.45) U and body weight increased from 71.68 (13.43) kg (BL) to 72.24 (12.88) kg. Hypoglycemia was reported in 5% of the subjects (8.5 events/ 100PYE) during the 12 months treatment period. The two most common reasons for prescribing degludec were to improve HbA1c (83.8%) and for control of fasting glucose (63.7%).
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.
J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. L. Murthy: None. B.D. Saboo: None. S. Yalamanchi: None. B. Ramanathan: Speaker's Bureau; Self; Novo Nordisk India Private Limited, Eli Lilly and Company, Boehringer Ingelheim, Sanofi-Aventis, Zydus Pharmaceuticals, USV Private Limited, DR.REDDY'S LABORATORIES, AstraZeneca, Biocon, Johnson and Johnson, MSD, Novartis, Glenmark, Abbott. S. Gupta: Speaker's 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.