Harpreet S. Bajaj, MD, MPH

Disclosures

September 08, 2017

Hi. My name is Harpreet Bajaj. I'm a community endocrinologist and research associate at Mount Sinai Hospital in Toronto. I'm going to give you a community clinician perspective on the DEVOTE trial results,[1] which were presented at the American Diabetes Association Conference.

DEVOTE Trial

The US Food and Drug Administration mandated that cardiovascular outcomes with degludec insulin be evaluated. The DEVOTE trial compared degludec with glargine, the market leader and most prescribed basal insulin in the world.

DEVOTE had a very pragmatic design, which is important for clinicians to recognize. Patients with an episode of hypoglycemia within the past 90 days were included, which is somewhat different from previous trials with insulin and other oral hypoglycemic agents, where such patients were excluded.

We see these patients in our clinic. These results are more "real life" and can be applied to the clinic more readily than other trial results.

Results

There was no statistically significant difference in the primary cardiovascular outcome between degludec and glargine, but it is important to recognize that the secondary adjudicated endpoints of prespecified severe hypoglycemia were significantly different with degludec insulin compared with glargine. There was about 40% less risk for severe hypoglycemia and about 53% less risk for nocturnal severe hypoglycemia with degludec.

If you look at the number-needed-to-treat perspective, you need to treat just over 50 patients for 2 years to reduce one episode of severe hypoglycemia. That is an impressive number. This was despite achieving the same glycemic targets; A1c at the end of the trial was the same for both degludec and glargine.

Real Hope for Minimizing Hypoglycemia?

Hypoglycemia is a real barrier for clinicians and patients when prescribing, initiating, and titrating insulin, especially basal insulin. Many community physicians and patients are afraid of hypoglycemia.[2,3,4] Studies suggest that patients may back off their insulin and eat more to avoid hypoglycemia, especially if it's occurring nocturnally.[5,6]

Hypoglycemia also affects families. Patients' families feel stress when looking out for the relative they care for and worry about whether nocturnal hypoglycemia is going to happen. This goes beyond the clinician/patient interaction and goes to the community and families as well.

Overall, we have made tremendous progress in insulin therapy over the past 90-some years, with the design of better insulins with better profiles. Degludec takes that to the next level, with reduced risk for hypoglycemia even compared with the current standard of care throughout the world.

Will Degludec Replace Glargine in the Real World?

The question is, will degludec replace glargine insulin when it comes to prescribing, initiating, or switching insulin in the real world? We made the transition from NPH insulin to the newer analogue insulins, glargine and detemir, just over 15 years ago. All of these data from the DEVOTE trial and SWITCH trials clearly outline the benefits [of degludec].

The benefits appear to be similar to what we saw from switching or transitioning from NPH to the analogue insulins. And the benefits in terms of hypoglycemia appear to be similar when we go from glargine insulin to degludec insulin.

Over time, we are going to see a transition where patients and physicians will be using this new insulin more than the one we already use a lot in our clinical practice.

Thank you for listening.

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