Alan Moses, MD, is the medical director for Novo Nordisk Pharmaceuticals

With the new basal-bolus insulin landscape, what is the most importantthing that endocrinologists and primary care physicians need to know sothat their insulin-using patients can follow the best possible regimen?

It is extremely important that, by concentrating on the specific needs of thepatient through diabetes education and by prescribing the “right” insulin for the“right” patient, the majority of patients can safely get to target glucose controlindividualized for that patient. Clinical trial data supporting the approval ofLevemir as the newest addition to Novo Nordisk’s insulin analogue portfolio, andexperience generated over the last year in Europe and other parts of the world,demonstrate the value of Levemir as a basal insulin in combination with oralanti-diabetes agents in type 2 diabetes, and in combination with rapid-actinganalogues for both type 2 and type 1 diabetes.

The challenge for the prescribing physician is to recognize the state of diabetesand whether the patient can respond to a basal insulin alone (in combinationwith oral agents), or whether the patient needs both a basal insulin and a bolus(pre-meal) component, either in the form of Levemir plus NovoLog or NovoLogMix 70/30. Clinical trial data suggest that when the A1C is above 8.5%-9%, itis more likely that the patient will respond better to basal-bolus treatment,although the primary goal is to get the blood glucose levels down to as low ascan be achieved safely. Rapid-acting insulin analogues such as NovoLog add aconvenience factor for mealtime administration and provide better post-mealglucose control than regular human insulin. In addition, new once-a-day basalinsulin analogues such as Levemir provide glucose control with no additional riskof hypoglycemia and low weight gain.

When should an endocrinologist or primary care physician entertain theidea of putting a type 2 patient on an insulin regimen?

We know from a number of important studies, such as the UKPDS [UnitedKingdom Prospective Diabetes Study] and the Kumamoto study, that patientswith type 2 diabetes can suffer all of the same adverse complications ofdiabetes as patients with type 1 diabetes. Thus, good glucose control is a veryimportant part of their overall management. Yet in the United States, there hasbeen a hesitancy to use insulin early in the course of diabetes because of theperception that it is complicated and not safe. Too many patients are exposed toexcessive glucose levels for too long without being afforded the advantages ofgood glucose control with insulin. Starting insulin early with a basal insulin likeLevemir before beta cell function deteriorates completely not only can achievegood glucose control safely, but may preserve beta cell function longer, and thusmake it easier to achieve good control for a longer time with a simple insulintreatment schedule.

What precautions should endos and PCPs take when starting a patient onan insulin regimen?

The key to starting insulin in any patient is to ensure that patients understandhow to administer the insulin, when to measure their blood glucose and how tomoderate their diet and exercise patterns to take account of the time (for short-actinginsulins) when insulin has its peak action. Thus, patient education is key tosuccessful insulin administration.It also is imperative that patients are taught how to monitor their own progressso that they can adjust insulin doses themselves to accommodate changesin their glucose control. Insulin delivery devices like FlexPen make it easier toteach patients how to use insulin and increase their confidence in their insulintreatment program. Physicians should start insulin doses at a low to moderatelevel so that patients do not experience episodes of hypoglycemia early in theirtreatment, as that discourages patients from achieving good levels of glucosecontrol.

How will Levemir change the way patients take insulin?

As a basal insulin lasting up to 24 hours and providing smooth absorption withexcellent efficacy and safety, Levemir provides patients with an insulin that canreliably lower blood glucose with a decreased risk of hypoglycemia and with lessweight gain. The label supports its use in both type 1 and type 2 diabetes and incombination with rapid-acting insulin before meals and with oral diabetes agentsin patients with type 2 diabetes who still have some residual insulin secretion tocover meals. FlexPen provides an accurate, safe, easy-to-teach, easy-to-learn andeasy-to-use means of administering Levemir. Importantly, the extended “in use”time of 42 days compared to 28 for other insulins is a real advantage to patients.

What should endos and PCPs know about the future of insulin therapy?

The future of insulin therapy increasingly will depend onbetter analogue insulins like Levemir, which can more closelyreproduce physiologic blood insulin profiles. In addition,with the advent of accurate and affordable continuousglucose-monitoring systems, it is likely that more patientscan be treated aggressively to achieve target levels ofglucose control that will reduce the risk of long-term diabetescomplications, while at the same time avoiding short-termcomplications such as hypoglycemia and weight gain. Weare likely to see increased emphasis on alternative routesof insulin administration, such as pulmonary insulin, whichare convenient for patients, but it still will be necessaryto demonstrate that this convenience can be translatedinto better glucose control. Novo Nordisk is committed tocontinuing to improve both the insulins and the deliverysystems that will allow patients to achieve the very bestdiabetes control.

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