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A Direct Efficacy and Safety Comparison of Insulin Aspart, Human Soluble Insulin, and Human Premix Insulin (70/30) in Patients With Type 2 Diabetes

¹ Third Medical Department Justus-Liebig University, Giessen, Germany
² Novo Nordisk Pharma, Mainz, Germany

Address correspondence and reprint requests to Reinhard G. Bretzel, Third Medical Department Justus-Liebig University, Rodthohl 6, 35392 Giessen, Germany. E-mail: reinhard.bretzel{at}innere.med.uni-giessen.de

OBJECTIVE—Because there are limited data on the comparison of insulin aspart and mixed insulin in type 2 diabetes, this trial was performed to compare the efficacy and safety of preprandial insulin aspart with human soluble insulin (HI) and human premix (70% NPH/30% regular) insulin (MIX).

RESEARCH DESIGN AND METHODS—A total of 231 type 2 diabetic patients were randomized to insulin aspart (n = 75), HI (n = 80), or MIX (n = 76) for 3 months. Insulin aspart and HI were administered with or without bedtime NPH insulin. A total of 204 patients completed the trial according to protocol. HbA_1c, 7-point blood glucose, insulin dosage, and hypoglycemic episodes were recorded. The primary end point was "change of HbA_1c" from baseline to last visit. Analysis for equivalence was performed by t tests with three subtests.

RESULTS—HbA_1c decreased 0.91 ± 1.00 for insulin aspart, 0.73 ± 0.87 for HI, and 0.65 ± 1.10 for MIX with the following confidence intervals: insulin aspart HI (–0.21 to 0.57, P = 0.025), insulin aspart MIX (–0.17 to 0.69, P = 0.092), and HI-MIX (–0.33 to 0.48, P = 0.006). Postprandial blood glucose decreased in the insulin aspart group: 0.44 mmol/l to >1.67 mmol/l compared with HI and 1.1 mmol/l to >1.67 mmol/l compared with MIX. Preprandial insulin doses were similar in the insulin aspart and HI groups (10–14.5 U). Hypoglycemic events per month were 0.56 HI, 0.40 insulin aspart, and 0.19 MIX.

CONCLUSIONS—Statistically, insulin aspart was not equivalent to another treatment in terms of HbA_1c reduction. Insulin aspart treatment resulted in improved HbA_1c and postprandial blood glucose. The application of insulin aspart was safe and well tolerated.

Abbreviations: HI, human soluble insulin • MIX, human premix insulin • OHA, oral hypoglycemic agent • WHO, World Health Organization

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