Initiating or Switching to Biphasic Insulin Aspart 30/70 Therapy in Subjects with Type 2 Diabetes Mellitus. An Observational Study

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Abstract
The Review of Diabetic Studies,2008,5,3,154-162.
Published:November 2008
Type:Original Article
Authors:
Author(s) affiliations:

Leif Breum1, Thomas Almdal2,3, Pia Eiken4, Per Lund5, Erik Christiansen6, on behalf of the Danish BIAsp Study Group

1Department of Medicine, Køge Hospital, Køge, Denmark.

2Department of Endocrinology, Hvidovre University Hospital, Copenhagen, Denmark.

3Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.

4Department of Cardiology and Endocrinology, Hillerød Hospital, Hillerød, Denmark.

5Department of Medicine, Helsingør Hospital, Helsingør, Denmark. 6 Novo Nordisk Scandinavia AB, Copenhagen, Denmark.

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/m2, duration of diabetes 9.1 ± 8.1 years and HbA1c (%) 9.4 ± 1.7. 199 subjects were prior insulin users and 193 were insulinnaïve 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.