OPTIN-D: Optimizing Patient-relevant outcomes with Toujeo (insulin glargine 300 U/ml) IN routine diabetes care. (WC2016-013)

OPTIN-D: Optimizing Patient-relevant outcomes with Toujeo (insulin glargine 300 U/ml) IN routine diabetes care.

Background

Starting date: 01/02/2015

 

Long-acting (basal) insulin analogs have contributed significantly to improved management of diabetes over the last decade. The first and most commonly used analog is insulin glargine 100 units/mL (Gla-100)1,2, which has a well-established mode of action and profile of efficacy and safety3-6. It has advantages compared with human NPH insulin, notably reduction of nocturnal and overall hypoglycemia2,7,8. This benefit is clinically relevant because, in addition to concerns about medical risks associated with hypoglycemia, fear of hypoglycemia is a leading barrier to starting and continuing insulin therapy9-11. However, hypoglycemia continues to be observed during Gla-100 treatment, suggesting that a basal insulin with an even flatter and longer profile of action might further improve safety and tolerability.

The new insulin glargine 300 units/mL (Gla-300) has a reduced redissolution rate following subcutaneous injection as compared with Gla-100 and thereby the potential for meeting this need12,13. Glucose clamp studies confirm that Gla-300 provides flatter and more prolonged pharmacokinetic and pharmacodynamic profiles than Gla-10012,13. The EDITION 1 study showed that Gla-300 controls HbA1c as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin but with consistently less risk of nocturnal hypoglycemia14.

In the position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) patient centered care is defined as an approach to “providing care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide all clinical decisions”15,16. There is good evidence supporting the effectiveness of a shared decision-making approach, in which clinicians and patients act as partners in order to reach a consensus on the therapeutic course of action17,18. According to the General Practitioners Clinical Guideline (NHG standard) and the National Diabetes Care Standard (NDF), individual treatment goals and plans should be set based on shared decision making. When the agreed goals are not reached, physician and patient can decide together on further actions including change of treatment19.20. Indications to start with insulin glargine 300 U/mL are: a) not satisfied with current treatment, b) in need of more flexibility, c) lower volume of insulin desired, and d) (fear of) hypoglycemia. To date, the considerations of patients and physicians to change treatment regimen and adjust treatment goals have so far received little attention. We therefore set out this study to examine not only the benefits of starting with insulin glargine 300 U/mL over time but also the process of shared decision making in relation to starting with insulin glargine 300 U/mL. The EDITION studies indicate that Toujeo improves patients’ well-being due to a reduction of hypoglycemic events and more flexibility14,19. In the proposed study we will document changes in Patient Reported Outcomes of people with type 2 diabetes over time after they have started using insulin glargine 300 U/mL in an observational study in real practice.

 

References
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