Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results

Abstract

Objective:

To investigate the safety and efficacy of switching to biphasic insulin aspart (BIAsp) 30, 50 or 70 in patients with type 2 diabetes previously treated with biphasic human insulin (BHI) 30/50 (with or without oral glucose-lowering drugs) in routine clinical practice.

Methods:

This was a 26-week, prospective, observational study conducted in Belgium and Luxembourg. Data were collected at baseline before patients switched and at 12 and 26 weeks after starting BIAsp 30, 50 or 70. Safety endpoints were incidence and rate of hypoglycemia (major, minor, nocturnal), adverse events and body-weight changes. Efficacy assessments included HbA_1c and 7-point self-measured plasma glucose (PG) profiles. Changes from baseline were analyzed using paired t-tests.

Results:

Of 592 patients analyzed, 72% switched to twice-daily BIAsp and 20% to three-times daily BIAsp. Upon switching, 27% of patients received intensified treatment (i.e., more daily doses than with their previous BHI). At all three data-collection points, approximately two-thirds of patients were taking BIAsp 30 and approximately one-third were taking BIAsp 50; very few patients took BIAsp 70. Mean total daily insulin dose increased significantly from baseline (51.2 U) to 26 weeks (54.3 U) and mean time of intake before meals changed from 17 minutes for BHI to ∼3 minutes with BIAsp. Incidence of hypoglycemia did not change during the study (baseline: 30.7%, week 26: 29.2%). HbA_1c improved significantly from baseline (7.9 %) to weeks 12 and 26 (7.6% and 7.5%, respectively; p < 0.001). Mean PG profiles also showed significant improvements. As this is an observational study, some limitations should be considered such as the absence of a control group and a possible bias of increased medical attention.

Conclusions:

Patients with long-standing type 2 diabetes can switch safely from BHI to BIAsp therapy, even if they receive intensified treatment, and they have no problems changing the timing of their insulin injections.

Keywords::

• Biphasic human insulin
• Biphasic insulin aspart
• Dosage
• Hypoglycemia
• Observational study
• Type 2 diabetes

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Erratum

Transparency

Declaration of funding

This study was funded by Novo Nordisk.

Declaration of financial/other relationships

F.N. has received speaker fees, advisory board payments and has been provided with travel to scientific meetings by various pharmaceutical companies. D.D’H. is an employee of Novo Nordisk Pharma. L.C. has received educational grants from Novo Nordisk and acted as consultant for Novo Nordisk Belgium.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors wish to express their thanks to all participating diabetologists for their active contribution to the study. They are also grateful to L.C. for the statistical analysis. The authors accept direct responsibility for this paper and are grateful to Watermeadow Medical Plc, Witney, UK (supported by Novo Nordisk A/S, Bagsvaerd, Denmark) for assistance in developing the draft manuscript from an agreed outline, and in collating comments.

This article was previously present at: the World Diabetes Congress 2011, held by the International Diabetes Federation in Dubai, United Arab Emirates from Sunday 4 December 2011 to Thursday 8 December 2011. The 3665 study (P 1167) and the elderly subanalysis (P-1136) were presented as posters at the IDF Congress.

Notes

*NovoMix is a registered trade name of Novo Nordisk, Denmark.