4.7 Article

Insulin administered by needle-free jet injection corrects marked hyperglycaemia faster in overweight or obese patients with diabetes

Journal

DIABETES OBESITY & METABOLISM
Volume 17, Issue 11, Pages 1093-1099

Publisher

WILEY
DOI: 10.1111/dom.12550

Keywords

clinical trial; insulin therapy; pharmacodynamics; pharmacokinetics; type 1 diabetes; type 2 diabetes; hyperglycaemia

Funding

  1. European Pharma Group B.V., Schiphol Rijk, the Netherlands

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Aims: To test whether jet injection of insulin resulted in faster correction of marked hyperglycaemia than when insulin is injected by a conventional pen in patients with diabetes. Methods: Adult, overweight or obese (BMI >= 25 and <= 40 kg/m(2)) patients with type 1 diabetes (n = 10) or insulin-treated type 2 diabetes (n = 10) were enrolled in a randomized, controlled, crossover study. On two separate occasions, patients were instructed to reduce insulin dose(s) to achieve marked hyperglycaemia (18-23 mmol/l). Subsequently, insulin aspart was administered either by jet injection or by conventional pen, in a dose based on estimated individual insulin sensitivity. Pharmacodynamic and pharmacokinetic profiles were derived from plasma glucose and insulin levels, measured for 6 h after injection. Results: After conventional injection, plasma glucose concentration dropped by >= 10 mmol/l after 192.5 +/- 13.6 min. The jet injector advanced this time to 147.9 +/- 14.4min [difference 44.6 (95% confidence interval 4.3, 84.8); P = 0.03], except in 3 patients who failed to reach this endpoint. The time advantage exceeded 1.5 h in patients with a BMI above the median. Jet injection also reduced the hyperglycaemic burden during the first 2 h (2042 +/- 37.2 vs 2168 +/- 26.1 mmol/min; P = 0.01) and the time to peak insulin levels (40.5 +/- 3.2 vs 76.8 +/- 7.7 min; P < 0.001), but did not increase the risk for hypoglycaemia. Conclusions: Administration of rapid-acting insulin by jet injection results in faster correction of marked hyperglycaemia in overweight or obese patients with insulin-requiring diabetes.

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