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)

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.

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