Clinical Medicine Insights: Endocrinology and Diabetes

Natasha M. Appelman-Dijkstra¹, Marjolein Sonneveld², Beril Tom² and Petronella H.L.M. Geelhoed-Duijvestijn¹

¹Department of Internal Medicine, Haaglanden Medical Centre The Hague, the Netherlands. ²Novo Nordisk B.V., Alphen aan den Rijn, the Netherlands.

Abstract

Aim:  An open label non-randomized observational study was performed to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) in NovoLet^® to biphasic insulin aspart 30/70 (BIAsp 30) in FlexPen^® in an outpatient setting; in terms of insulin dose, efficacy, hypoglycemic episodes, quality of life (WHO-5) and treatment satisfaction (ITSQ; Insulin Treatment Satisfaction Questionnaire).

Methods:  Type 2 diabetic patients (aged ≥ 18 yrs) treated with BHI30 in NovoLet^® who were switched to BIAsp 30 in FlexPen^® were included in an open-labeled, multicenter, non-randomized, observational study. At baseline and 8 ±  2 weeks after switching to BIAsp 30 FlexPen^® HbA^1c, insulin dose, number of hypoglycemic events and quality of life were measured.

Results:  A total of 196 patients (54.3% female, aged 64.8 ±  12 years) with type 2 diabetes completed the study. Total insulin dose remained stable 52.8 ±  24.9 units at baseline vs. 52.0 ±  25.6 units after 8 weeks of treatment, as did HbA1c, 7.7 ±  1.4% at baseline vs. 7.7% ±  1.4%. No weight change was reported (81.6 ±  16.6 kg vs. 81.5 ±  16.7 kg). With BIAsp 30, a significantly lower number of total hypoglycemic episodes were reported (127 compared to 188 with BHI 30, p < 0.001). Significance remained for the subclasses separately (daytime 142 vs. 98, p =  0.005; and nocturnal 46 vs. 29, p =  0.05).

ITSQ results confirmed these findings: total score on ‘hypoglycemic’ subscale improved significantly from 78 ± 16.8 to 83 ± 16.0 (p = 0.009). The overall score improved significantly from 82.2 ± 14.6 to 85.5 ± 13.9 (p = 0.036). 85% percent of the patients were satisfied with the FlexPen^® device and 89.1% wanted to continue treatment with FlexPen^®. The WHO-5 scores after the final visit showed no general quality of life problems with average scores between 2.7 and 3.3.

Conclusion:  The results of this study provided evidence that switching from BHI 30 NovoLet^® to BIAsp 30 FlexPen^® can be done easily on a unit by unit basis in daily practice in type 2 diabetic patients. After 8 weeks of treatment with BIAsp 30 there was a significant decrease in hypoglycemic episodes accompanied by a significant increase in treatment satisfaction.

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