Research conducted at the Baylor College of Medicine suggests that the new ultra-long-acting insulin (Insulin degludec or Tresiba) is not frequently associated with episodes of hypoglycemia (or low blood sugar levels) when compared to the traditional formulations of insulin glargine.
These results were compiled after a detailed analysis of five clinical trials that were conducted at BCM. The analytical data will be presented on this Tuesday in San Francisco at The Endocrine Society’s 95th Annual Meeting.
Details of the study:
The study was conducted on known type 2 diabetics who were either prescribed a once daily injection of insulin degludec or glargine combined along with insulin (with meals) or oral diabetic medications.
A total of 3400 diabetics were enrolled in the study (of which, 2,262 were put on insulin degludec and 1,110 were given insulin glargine). Of the 5 clinical trials conducted, the initial 4 trials (insulin-oral therapy trials) tested the comparative activity of insulin glargine and insulin degludec with oral hypoglycemics. The 5th study (or (insulin-only therapy) assessed the competitive activity of two large acting insulins with fast-acting mealtime insulin, called aspart.
The results suggested:
– 43% patients on insulin glargine reported recurrent hypoglycemic attacks, as opposed to 38% patients who were put on insulin degludec, in the insulin-only trial.
– 6.1% patients on insulin degludec reported hypoglycemic episodes, as opposed to 6.6% with glargine, in the insulin-oral therapy trials.
The abstract suggested that there was no notable difference in the rates of development of recurrent hypoglycemic episodes in all 5 trials. However, in the insulin-only trial, 27 percent lesser hypoglycemic episodes were reported with insulin degludec as compared to insulin glargine.
The principal investigator of the study, Dr. Alan Garber, who is also professor of medicine, biochemistry and molecular biology, and molecular and cellular biology at Baylor College of Medicine stated: “This study shows that insulin degludec is an appropriate therapy for use in different treatment regimens for patients with type 2 diabetes.”
Almost 33% of diabetics (or 1/3 of entire diabetic population) depend on insulin therapy for control of blood sugar levels. In all patients who rely on insulin, recurrent hypoglycemic episodes is one of the notable complaints. Garber went on to say: “Decreasing the risk of hypoglycemia in diabetic patients is a benefit to both the patient and the insurer.”
Although the U.S. Food and Drug Administration has not yet approved Insulin degludec, it is commercially available in some other countries. The longer duration of activity of Insulin degludec as compared to insulin glargine may pose a risk of hypoglycemia episodes that must be tested and investigated, as suggested by Garber::
“Compared with insulin glargine, insulin degludec may offer considerable benefits by reducing the major side effect of insulin therapy, hypoglycemia”
Recurrent hypoglycemia was defined in the study as a blood glucose concentration of less than 56 mg/ dL with a frequency of at least two episodes within 24 hours.