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)

Kesavadev, Jothydev and Gowda, Ambanna and Kumar, Harish and Yalamanchi, Sadasiva Rao and Lodha, Sailesh and Singh, Kiran Pal and Basu, Debasis and Asirvatham, Arthur and Shah, Navneet and Pathan, Muzammil Khan and Revanna, Manjunatha and Mukherjee, Jagat Jyoti (2021) 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). Medical Sciences, 10 (1). p. 1. ISSN 2076-3271

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Abstract

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.

Item Type: Article
Subjects: Universal Eprints > Medical Science
Depositing User: Managing Editor
Date Deposited: 18 Nov 2022 04:17
Last Modified: 26 Aug 2023 06:26
URI: http://journal.article2publish.com/id/eprint/224

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