Drug products: Apidra, Apidra (OptiClik), Apidra (OptiSet), Apidra (SoloStar)
ATC code: A10AB06
Substances: insulin glulisine
Controlled studies on differences between men and women are lacking. A retrospective analysis of four randomized trials has shown a possible higher risk of nocturnal and symptomatic hypoglycemia in women.
Women have been included in published pharmacokinetic studies, but results have not been presented separately for men and women. The producer does not deem different doses according to patient sex to be necessary .
No studies with a clinically relevant sex analysis regarding the effect of insulin glulisine have been found.
One study retrospectively analysed four large trials including 713 patients (378 men, 335 women) with type 2 diabetes. Insulin glulisine was added to a basal treatment with oral antidiabetic drugs (OAD) and insulin glargine. Female sex was identified as a predictor of nocturnal and symptomatic hypoglycemia (OR 1.82; 95 % CI 1.07-3.11 and OR 1.89; 95% CI 1.31-2.78) . Furthermore, several meta analyses have shown similar data [2-4].
Concurrent administration of insulin glulisine and oral contraceptives may decrease the effect of insulin glulisine . Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner).
Insulin glulisine can be used in pregnant women. Insulin requirements may change during pregnancy, and quickly return to normal after delivery . Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Two observational studies from the 1990’s with a total of 418 patients (43 men, 374 women) reported intentional insulin omission among 1/3 of women to control their weight [6,7].
In a retrospective study in 124 women, perimenstrual changes in selfreported glucose concentrations were found in 61%. Use of oral contraceptives did not diminish variability in blood glucosis . In another study based on questionnaires (406 women) 67% of the participants reported changes in blood glucose levels or glycosuria premenstrually and 70% during the menstrual phase. Those with more cravings had larger elevations in blood glucosis levels suggesting that giving in to cravings might cause the changes .
Date of litterature search: 2017-09-20
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson