Author Interviews, Diabetes, FDA, JAMA / 07.03.2021
Diabetes: Risk of Hypoglycemia With Long Acting Insulin in Older Patients
MedicalResearch.com Interview with:
Marie C. Bradley, PhD, MPharm, MScPH
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, Maryland
MedicalResearch.com: What is the background for this study?
Response: Long-acting insulin analogs, insulin glargine (glargine) and insulin detemir (detemir) are increasingly used in the management of type 2 diabetes mellitus (T2DM). In recent years the price of long-acting insulin analogs has increased substantially2 Higher costs for these insulin analogs may limit patient access.1 Clinical trials showed the risk of severe hypoglycemia did not differ between long-acting insulin analogs and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus (T2DM). An observational study examining severe hypoglycemia in T2DM patients found similar results. However, these previous studies did not focus on patients aged ≥65 years, who are at an increased risk for hypoglycemia, or did not include patients with concomitant prandial insulin use. Therefore, to investigate this further we used Medicare data to assess the risk of severe hypoglycemia among older T2DM patients who initiated a long acting analog ( glargine or detemir) compared to NPH in real-world settings.
(more…)