Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study

Abstract

Objective: To investigate tolerability and glycemic control over 26 weeks in patients with type 2 diabetes (T2D) who initiated insulin with, or switched to, biphasic insulin aspart 30/70 (BIAsp 30) in routine clinical care.

Methods: This was a non-randomized, non-interventional, open-label, observational study involving patients under the care of approximately 150 insulin-prescribing physicians in Denmark. All patients enrolled were prescribed BIAsp 30 in routine care. Starting dose, dose titration and injection frequency were determined individually by each physician. Information on serious adverse drug reactions (SADR), glycemic parameters and hypoglycemic events were obtained from patients' notes, patients' diaries and recall, and transferred to case report forms by physicians at baseline (during 4 weeks prior to BIAsp 30 therapy) and after 12 and 26 weeks of treatment.

Results: 421 subjects were recruited and 392 provided safety data. The age (mean +/- SD) was 62.0 +/- 11.4 years, body mass index (BMI) 30.4 +/- 6.4 kg/m(2), duration of diabetes 9.1 +/- 8.1 years and HbA1c (%) 9.4 +/- 1.7. 199 subjects were prior insulin users and 193 were insulin-naïve patients. Four patients reported a SADR (3 hypoglycemia, 1 severe hypoglycemia). HbA1c was significantly reduced after 26 weeks of BIAsp 30 therapy: prior insulin users -1.2%, insulin-naïve patients -2.2% (both p < 0.001). 28% and 41% of patients, respectively, reached target HbA1c < 7%. Overall the hypoglycemia rate was lower for insulin-naïve patients than for prior insulin users: 5.0 vs. 6.6 episodes/patient-year (p < 0.05).

Conclusion: Initiating insulin with, or switching insulin to, BIAsp 30 in routine care was safe and effective in patients with T2D.

Figures

Figure 1. Diagram of patient flow through the study

ITT: intention-to-treat, n: number of patients.

Figure 2

HbA1c levels at baseline and after 12 and 26 weeks of BIAsp 30 therapy, for prior insulin users and for previously insulin-naïve patients. Error bars are SD. ***p < 0.001 compared with baseline.

Figure 3

The proportions of prior insulin users and insulin-naïve patients who reached HbA1c targets

Figure 4

Self-measured fasting plasma glucose (FPG) levels at baseline and after 12 and 26 weeks of BIAsp 30 therapy, for prior insulin users and for previously insulin-naïve patients. Error bars are SD. **p < 0.01, ***p < 0.001.

Figure 5

Patient weight at baseline and after 12 and 26 weeks of BIAsp 30 treatment, for prior insulin users and previously insulin-naïve patients. p-values refer to differences from baseline. Error bars are SD. *p < 0.05, **p < 0.01.