A Comparison of Human Ultralente‐and Lente‐based Twice‐daily Injection Regimens

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Abstract
The problem of fasting hyperglycaemia remains unresolved on currently used twice‐daily injection regimens. Human ultralente insulin is of longer duration than human lente and differs from it only in the nature of the zinc‐insulin complex. In a 6‐month double‐blind crossover study these insulins were compared in 66 patients who were randomized to human ultralente or human lente insulin given together with human soluble insulin in a twice‐daily injection regimen. Patients were seen monthly and crossed over after 3 months treatment. Fasting blood glucose concentrations on the ultralente regimen were considerably lower than on the lente regimen, the difference being statistically significant (6.6 ± 0.5 vs 8.2 ± 0.5 mmol I−1, p < 0.05), but only present in those patients with fasting concentrations below the median. Glycosylated haemoglobin was identical on both regimens (9.3 ± 0.2 %). The evening ultralente dose was slightly but significantly lower than the evening lente dose (14.9 ± 0.8 vs 15.5 ± 0.8 U, p < 0.05) thus endorsing the lowering effect of ultralente on the fasting blood glucose concentration. However, the incidence of serious hypoglycaemic events was higher on the ultralente regimen (0.38 ± 0.10 vs 0.09 ± 0.04 events per patient‐month, p < 0.02), the majority of nocturnal events occurring between 0500 h and breakfast. We conclude that ultralente insulin can give an improved fasting blood glucose concentration but that in those patients with more marked fasting hyperglycaemia or with a nocturnal hypoglycaemia problem it offers no clinical advantage over human lente insulin in a twice‐daily injection regimen.