The Biosulin equivalence in standard therapy (BEST) study − a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus

David Grant Segal, Daniela Tupy, Larry A Distiller


Introduction. The need for more cost-effective insulin therapy is critical in reducing the burden on patients and health systems. Biosimilar insulins have the potential to dramatically lower healthcare costs by delivering insulin with a similar anti-glycaemic effect and adverse reaction profile.

Objectives. The purpose of this study was to confirm equivalence in glycaemic outcomes and side-effect profiles between Biosulin 30/70 and other human premixed insulin preparations on the South African market in a clinical practice setting.

Methods. Subjects in this interventional, observational, multicentre, open-label, prospective study were switched from their existing human premix insulin (Actraphane, Humulin 30/70 or Insuman) to the study insulin Biosulin 30/70. The primary endpoint was the change in HbA1c from baseline to 6 months.
Results. Seventy-seven adult patients with type 1(n=18) or type 2 (n=59) diabetes were enrolled. The baseline HbA1c in the overall cohort was 7.9%, 8.0% at 3 months (p=0.50) and 7.6% at 6 months (p=0.14).There was a small increase in the total daily dose of insulin used in both the type 1 and type 2 cohort, from 0.62 to 0.65 units/kg/day (p=0.0004). There was no significant difference in weight in the study subjects during the 6-month period on Biosulin 30/70 (p=0.67).

Conclusion. Biosulin 30/70 achieved at least equivalent glycaemic control to existing human premix insulins, with no reported new or severe adverse events. Increased use of biosimilar insulins has the potential for significant cost savings. 

Authors' affiliations

David Grant Segal, Department of Paediatrics, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

Daniela Tupy, Department of Internal Medicine, Hillbrow Community Hospital, Johannesburg, South Africa

Larry A Distiller, Centre for Diabetes and Endocrinology, Johannesburg, South Africa

Full Text



diabetes; biosimilar; insulin

Cite this article

South African Medical Journal 2013;103(7):458-460. DOI:10.7196/SAMJ.6345

Article History

Date submitted: 2012-09-26
Date published: 2013-04-02

Article Views

Abstract views: 2649
Full text views: 7364

Comments on this article

*Read our policy for posting comments here