A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes

Annelie Carlsson, Gun Forsander, Johnny Ludvigsson, Sara Larsen, Eva Ortqvist, Swedish PREDICTIVE-Youth Study Group, Annelie Carlsson, Gun Forsander, Johnny Ludvigsson, Sara Larsen, Eva Ortqvist, Swedish PREDICTIVE-Youth Study Group

Abstract

This 26-wk observational study in children and adolescents with type 1 diabetes (T1D) in Sweden investigated the safety and efficacy of insulin detemir (IDet) in newly diagnosed (ND) patients and those with established diabetes (ED) switching to IDet. A total of 159 patients initiated IDet as part of basal-bolus therapy, 59 in the ND stratum (mean age 9.7 yr) and 97 in the ED stratum (mean age 12.5 yr). The primary outcome measure was the incidence of severe adverse drug reactions; just one major hypoglycemic event occurred in a patient in the ND stratum during the study and one patient was withdrawn due to injection-site reactions. All other events were classified as mild. In the ED stratum, there was a reduction in hypoglycemic events in the 4 wk prior to study end from baseline (mean reduction of 2.46 events, not significant) and a significant reduction in nocturnal hypoglycemia (mean reduction of 2.24 events, p = 0.0078). Glycemic control improved in the ND stratum as expected and, in the ED stratum, there was no significant change in HbA1c from baseline (mean reduction of -0.45%). At study end, mean daily IDet doses were 0.39 U/kg (ND) and 0.54 U/kg (ED). Weight increased by 5.7 and 2.0 kg in the ND and ED strata, respectively, and was within the normal limits for growing children. IDet provided good glycemic control and was well tolerated, with a reduced risk of nocturnal hypoglycemia in a heterogeneous cohort of children and adolescents with T1D.

Keywords: detemir; pediatrics; safety; type 1 diabetes.

© 2013 John Wiley & Sons A/S.

Figures

Figure 1
Figure 1
Subject disposition.
Figure 2
Figure 2
Change in mean number of nocturnal hypoglycemic events in the ED stratum. Change (baseline to 26 wk) in mean number of events in the 4 wk prior to data collection for established diabetes (ED) stratum. *p

Figure 3

Change from baseline in (A)…

Figure 3

Change from baseline in (A) HbA1c and (B) fasting plasma glucose after 26…

Figure 3
Change from baseline in (A) HbA1c and (B) fasting plasma glucose after 26 wk’ treatment with IDet in the ED stratum. Data are mean ± SEM. Change is for the observed cases (OC) population in the established diabetes (ED) stratum. FPG, fasting plasma glucose; IDet, insulin detemir.

Figure 4

Change in standardized body mass…

Figure 4

Change in standardized body mass index (BMI). ED, established diabetes; ND, newly diagnosed;…

Figure 4
Change in standardized body mass index (BMI). ED, established diabetes; ND, newly diagnosed; SD, standard deviation.
Figure 3
Figure 3
Change from baseline in (A) HbA1c and (B) fasting plasma glucose after 26 wk’ treatment with IDet in the ED stratum. Data are mean ± SEM. Change is for the observed cases (OC) population in the established diabetes (ED) stratum. FPG, fasting plasma glucose; IDet, insulin detemir.
Figure 4
Figure 4
Change in standardized body mass index (BMI). ED, established diabetes; ND, newly diagnosed; SD, standard deviation.

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