The OPT2MISE Study – A Review of the Major Findings and Clinical Implications

European Endocrinology, 2015;11(2):70–4 DOI: http://doi.org/10.17925/EE.2015.11.02.70

Abstract:

Many patients with type 2 diabetes struggle to achieve adequate glucose control despite escalation of therapy including complex insulin regimens with multiple daily injections (MDIs). Previous randomised controlled trials failed to show a significant improvement in glycaemic control with pump therapy over multiple injections. The OPT2MISE study enrolled 495 adult patients with poorly controlled type 2 diabetes despite an intensified insulin regimen using rapid and slow-acting insulin analogues. After a 2-month run-in period, patients were randomised to switch to pump therapy or to maintain their MDI regimen. After 6 months, patients with pump therapy achieved a better glycaemic control than those who used multiple injections (glycated haemoglobin [HbA1c] difference of -0.7 %), and twice as many patients reached the target range of 8 % or less in the pump-therapy group compared with the injection group. Patients using pump therapy had a 20 % reduction of their total daily insulin dose. A moderate weight gain was observed with both treatments, and no severe hypoglycaemia nor ketoacidosis occurred in the pump therapy group. Pump therapy may now be considered as a valuable option in type 2 diabetes patients who fail to respond to an intensified insulin regimen.
Keywords: External insulin pump, CSII, type 2 diabetes, intensified insulin therapy, anti-GAD antibodies, C-peptide
Disclosure: Yves Reznik has carried out clinical trials as co-investigator for Eli-Lilly, Medtronic and Novo-Nordisk, provided advisory services to Abbott, Eli-Lilly and Medtronic and attended conferences organised by Eli-Lilly and Medtronic as contributor. Michael Joubert has carried out clinical trials as co-investigator for Eli-Lilly, Medtronic and Novo-Nordisk, has provided advisory services to Abbott and Medtronic and attended conferences organised by Abbott, Eli Lilly and Medtronic as a contributor. No funding was received for the publication of this article.
Compliance with Ethics: The analysis in this article is based on previously conducted studies, and does not involve any new studies of human or animal subjects performed by any of the authors.
Received: June 02, 2015 Accepted July 08, 2015
Correspondence: Yves Reznik, Endocrinology and Diabetes Department, CHU Côte de Nacre, 14033 Caen Cedex, France. E: reznik-y@chu-caen.fr
Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit.

In type 2 diabetes (T2D), the addition of basal insulin is an option when oral therapy does not maintain acceptable glycaemic control. For the 50–60 % of patients who become refractory to basal insulin therapy alone1,2 treatment intensification requires the addition of prandial insulin to target control of post-prandial hyperglycaemias. The resulting regimen of multiple injections of rapid-acting insulin with basal insulin (MDI) achieves target glycaemia in only 70 % of patients, the remaining corresponding to MDI failure.3 As an alternative, glucagon-like peptide-1 (GLP-1)-receptor agonists should be combined with basal insulin, this association thus providing equal efficacy compared with the combined basal bolus strategy and giving other advantages, such as weight loss and reduction of the hypoglycaemia rate.4–7 The use of external pumps in patients with T2D is a recent practice compared with that in type 1 diabetes. In only a few countries, including France, Sweden and Israel, is continuous subcutaneous insulin infusion (CSII) using an external pump an alternative to multiple injection therapy in T2D and can also be reimbursed by the relevant health authorities. Before 2014, clinical trials evaluating pump therapy in T2D were scarce8–11 and retrospective reports on its use in clinical practice were rather limited.12–16 In 2014, the large multicentre, controlled trial, OPT2MISE, which compared pump therapy with multiple injections in insulin-treated patients with T2D demonstrated the superiority of CSII over multiple injections and better defined which patients may be a candidate for pump therapy.17 In this review, the state of the art concerning the use of CSII in T2D before OPT2MISE and the major findings and lessons from the OPT2MISE trial will be overviewed.

Pump Therapy in Type 2 Diabetes before OPT2MISE

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Keywords: External insulin pump, CSII, type 2 diabetes, intensified insulin therapy, anti-GAD antibodies, C-peptide