Clinical data on the use of intravenous (iv.) insulin aspart (IAsp) for the management of inpatient hyperglycemia are limited. This study evaluated the safety and efficacy of iv. IAsp in normal clinical practice in India.Materials & methods:
This was an open-label, nonrandomized, noninterventional, observational study of 3024 hospitalized subjects (67% intensive care unit [ICU] and 33% non-ICU) requiring iv. insulin. The decision to initiate iv. IAsp and decisions on dose/dosing frequency were made by the physician. Glucose testing was carried out according to local protocol in each center. The primary objective was to evaluate the incidence and type of adverse events/serious adverse events during therapy. Secondary objectives included physician-reported mean blood glucose (BG) measurements, duration of iv. treatment and total insulin dose, BG 24 h after transferring to subcutaneous (sc.) therapy, number of hypoglycemic events, mortality and ease of transferring from iv. to sc. administration.Results:
iv. IAsp reduced the mean BG from 19.8 mmol/l at treatment start to 8.6 mmol/l at treatment end. Similar results were observed in ICU (20.7–8.4 mmol/l; p = 0.0001) and non-ICU (17.7–8.9 mmol/l; p = 0.0001) settings. Serious adverse events were reported in six patients (0.2%), none were considered to be related to study medication. Rates of major and minor hypoglycemia were 0.6 and 2.8%, respectively. Most physicians (98.6%) expressed a preference to use IAsp in the future owing to rapid achievement of target BG, positive safety profile and convenience of shifting from iv. to sc. administration.Conclusion:
iv. IAsp is an effective and well-tolerated option for managing inpatient hyperglycemia in ICU and non-ICU settings.