Clinical use and efficacy of biphasic insulin lispro 50/50 in people with insulin treated diabetes – a nationwide evaluation of clinical practice

Abstract

Objectives:

This study aims to investigate the metabolic effects of biphasic insulin lispro 50/50 in routine clinical practice. A total of 229 patients who were ≥18 years old with diabetes, newly treated with biphasic insulin lispro 50/50, were sourced from six secondary care services in England.

Methods:

Detailed clinical parameters were compared at baseline, and 3 and 6 months post-initiation. Responders was defined as those with HbA1c <7.5% (58 mmol/mol) and/or an HbA1c reduction of >1% (11 mmol/mol) at 6 months.

Results:

HbA1c showed significant reduction: −0.93% (−10 mmol/mol) and −1.2% (−13 mmol/mol) at 3 and 6 months respectively, while no significant change was noted for all the other parameters. When analyzed according to frequencies of injections/day, the greatest reduction was observed with the three times a day regimen (−1.0% [−11.0 mmol/mol] and −1.3% [−14.6 mmol/mol] at 3 and 6 months respectively). HbA1c reduction was greatest in the group who previously received a basal–bolus insulin regimen: (−0.8% [−9.0 mmol/mol] and −1.5% [−16.2 mmol/mol] at 3 and 6 months respectively). Reduction in weight was observed at 3 months (−1.8 kg ± 4.3) only for those who were previously on a basal–bolus insulin regimen. Insulin doses increased following conversion to biphasic insulin lispro 50/50, irrespective of the types of insulin used prior to biphasic insulin lispro 50/50, but this was not associated with weight gain. The independent predictors of response to biphasic insulin lispro 50/50 were baseline HbA1c, Caucasian, presence of nephropathy, prior use of basal–bolus insulin and prior use of other premixed combination.

Conclusion:

Biphasic insulin lispro 50/50 is therefore an effective therapeutic option for achieving glycemic control in patients with suboptimal HbA1c levels, especially among those who were previously on a basal–bolus insulin regimen and those who received it three times daily, with a neutral effect on weight parameters.

Limitations:

This was a retrospective study of routine clinical practice and is therefore limited by allocation bias and some missing data. Information on rates of hypoglycemia and quality of life are not available.

Keywords: :

• Biphasic insulin lispro 50/50
• HbA1c
• Insulin
• Routine clinical practice

Transparency

Declaration of funding

This study was funded by an unrestricted grant from Eli Lilly Pharmaceutical. Eli Lilly provided no further input in data acquisition, data access, analysis and interpretation of the data.

Declaration of financial/other relationships

I.I. has disclosed that he has received research grants and speaker fees from Eli Lilly and Novo Nordisk. J.E. and A.F.L. have disclosed that they have received speaker fees from Eli Lilly, MSD, Novo Nordisk, Sanofi, and have also received advisory board fees from Sanofi. M.B. has disclosed that she has received speaker fees from Eli Lilly, Boehringer Ingleheim, and advisory board fees from Novo Nordisk. N.K.M and J.M have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study.

CMRO peer reviewer 1 has no relevant financial or other relationships to disclose. CMRO peer reviewer 2 has received grants from the Russian Scientific Foundation; is a consultant to and the national coordinator of RTCs for AstraZeneca and AbbVie; and is on the Speakers’ Bureau of Eli Lilly, Novartis, Novo Nordisk, MSD and AztraZeneca.

Acknowledgments

We would like to thank Lilly and Company for providing an unrestricted grant towards this project.

Notes

*Humalog Mix50 is a registered trade name of Eli Lilly and Company, Hampshire, UK.

†Humalog 75/25 is a registered trade name of Eli Lilly and Company, Hampshire, UK.