American Diabetes Association 73rd Scientific Sessions | June 21-25, 2013 | Chicago, IL

Safety Of Intravenous Insulin Aspart And Regular Human Insulin In Hospitalized

Patients: An Indian Experience
Session Publish Only

Published Only
Number 2549-PO
Category Clinical Therapeutics/New Technology–Insulins

Author(s) MANOJ S. CHAWLA, ANIL BHORASKAR, H SHAH, S SHINDE, Mumbai, India

Hyperglycaemia is one of the common co-morbid conditions in hospitalized patients leading to complications and
increased in-hospital mortality. Intravenous (IV) insulin with/without adjunctive subcutaneous insulin is the mainstay of
treatment. We did an observational study to assess the safety of IV Insulin Aspart (IAsp), Regular Human Insulin (RHI)
in hospitalized patients in India.
Total (N) 203 patients were randomized; 103 to IV IAsp (group I) and 100 to IV RHI (group II), respectively. Safety was
assessed by frequency and severity of adverse events (AEs) & serious adverse events (SAEs) during hospitalization.
Mean age was 60.83 years, duration (0- >20years) in both groups, male to female ratio 5:1 with 80 & 73 insulin naïve
patients in IAsp or RHI group respectively.
No SAE was reported. Percentage of patients who had at least one adverse event was same of ~ 44% in both the
groups.
Table 1- Reported adverse events during the study
Events Group I N=103 Group II N=100
Severity No. % No. %
Mild 34 75.6 29 65.9
Moderate 11 24.4 15 34.1
Severe 0 0.0 0 0.0
Hypoglycemic Events
Major 3 2.9 0 0
Minor 5 4.8 3 3

The reported adverse events were related to their cause of hospitalization and unlikely due to insulin therapy as per
physicians’ causality assessment. All patients recovered from AEs. There was no statistical significant difference found
between both the groups either in severity/type of AEs or in terms of insulin infusion rate, infusion time and amount of
dextrose infused as rescue medication.
This observational study has shown the similar favourable safety profile of both IV IAsp and IV RHI in hospitalized
patients.

Keywords Hyperglycemia, Hospital Patients

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