Safety of Insulin Degludec/Insulin Aspart in Patients with Diabetes Mellitus over a Period of 1 Year during Routine Clinical Care in India: SMART (Study of Management of Diabetes with Ryzodeg™ Treatment)

• Published in: Medical sciences (Basel) 2021-12, Vol.10 (1), p.1
• Main Authors: Kesavadev, Jothydev, Gowda, Ambanna, Kumar, Harish, Yalamanchi, Sadasiva Rao, Lodha, Sailesh, Singh, Kiran Pal, Basu, Debasis, Asirvatham, Arthur, Shah, Navneet, Pathan, Muzammil Khan, Revanna, Manjunatha, Mukherjee, Jagat Jyoti
• Format: Article
• Language: English
• Subjects: Adult; Aged; Blood Glucose; Clinical medicine; Diabetes; diabetes mellitus; Diabetes Mellitus - chemically induced; Diabetes Mellitus - drug therapy; Drug dosages; Fasting; Female; Glucose; glycemic control; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents - adverse effects; IDegAsp; India; Insulin; Insulin Aspart - adverse effects; insulin therapy; Insulin, Long-Acting; Male; Middle Aged; Patients; safety; Values
• ISSN: 2076-3271; 2076-3271
• DOI: 10.3390/medsci10010001

This post-authorization study was conducted to evaluate the safety of insulin degludec/insulin aspart (IDegAsp) in adult patients with diabetes mellitus (DM) during routine clinical care under a real-world setting in India. Eligible patients received IDegAsp for a minimum of 12 months during routine clinical management. Data were collected at 0, 3, 6, and 12 months. In total, 1029 adult patients with DM were included; 65.2% (n = 671) were men; mean age was 55.0 ± 12.2 years, and the mean duration of diabetes mellitus was 10.8 ± 7.4 years. Thirty adverse events were reported in 23 patients (2.2%) during the follow-up: two adverse events in two patients were serious with fatal outcomes, which were unrelated to IDegAsp use. At baseline, there were 176 confirmed hypoglycemic events in 67 (6.7%) patients while they were on their previous treatment options. At 12 months of treatment with IDegAsp, 11 confirmed hypoglycemic events were reported in 11 (1.1%) patients since the previous visit; there were no reported episodes of severe hypoglycemia. Mean glycosylated hemoglobin value reduced from 9.5% ± 1.8% at baseline to 7.7% ± 1.1% at 12 months. This study showed the safety of IDegAsp in patients with diabetes mellitus over a period of 1 year during routine clinical care.