The Switch Study: Switching from BHI 30 Novolet to BIAsp 30 Flexpen: Clinical Observations from the Netherlands. Treatment Satisfaction when Switching from BHI 30 NovoLet® to BIAsp 30 FlexPen®

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

Fasting and meal-stimulated serum C-peptide in long-standing type 1 diabetes mellitus

Aims: This study aims to evaluate the stability of C-peptide over time and to compare fasting C-peptide and C-peptide response after mixed-meal tolerance test (MMTT) at T90 or T120 with C-peptide area under the curve (AUC) in long-standing type 1 diabetes. Methods: We included 607 type 1 diabetes individuals with diabetes duration >5 years. C-peptide concentrations (ultrasensitive assay) were collected in the fasting state, and in a subpopulation after MMTT (T0, just prior to, T30-T60-T90-T120, 30–120 min after ingestion of mixed-meal) (n = 168). Fasting C-peptide concentrations (in n = 535) at Year 0 and Year 1 were compared. The clinical determinants associated with residual C-peptide secretion and the correspondence of C-peptide at MMTT T90 / T120 and total AUC were assessed. Results: A total of 153 participants (25%) had detectable fasting serum C-peptide (i.e ≥ 3.8 pmol/L). Fasting C-peptide was significantly lower at Year 1 (p 5 years of diabetes duration. T90 and T120 MMTT measurements showed good concordance with the MMTT total AUC. Overall, there was a decrease of C-peptide at 1-year follow-up