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A case series of 10 patients with newly diagnosed type 1 diabetes provides insight into the beneficial effects of off-label semaglutide use on insulin use, HbA1c, and fasting C-peptide levels among this patient population.
Could a staple in the management of type 2 diabetes hold the key to eliminating the need to inject insulin in type 1 diabetes?
Results of a new study from the State University of New York at Buffalo (University at Buffalo) suggest use of semaglutide in people with newly diagnosed type 1 diabetes eliminated the need for mealtime insulin doses among the entire study cohort and allowed 70% to eliminate basal insulin use within 6 months, with the mean HbA1c decreasing from 11.7% at baseline to 5.9% at 6 months and 5.7% at 12 months.1
“We were definitely surprised by our findings and also quite excited. If these findings are borne out in larger studies over extended follow-up periods, it could possibly be the most dramatic change in treating Type 1 diabetes since the discovery of insulin in 1921,” said lead investigator Paresh Dandona, MD, PhD, former chief of the Division of Endocrinology in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.2
The GLP-1 receptor agonist class, particularly semaglutide, has been in the spotlight of the medical community in recent years as revelations surrounding its potential in chronic weight management have come to light. During this time, the popularity of semaglutide has grown to the point where demand for use as a weight loss agent, both on and off-label, has resulted in the agent’s listing on the FDA Drug Shortages database.3
The rising popularity of the agent could continue, particularly in off-label use, given the results of the current study, which was led by Dandona and colleagues with an interest in examining how agents used in type 2 diabetes could be used in management of type 1 diabetes. Of note, in 2011, Dandona led a study examining the effects of liraglutide in people with type 1 diabetes.1
In the current study, which was a case series of 10 patients, investigators detailed the effects of semaglutide use in a group of 10 patients aged 21-39 years who received treatment at the University at Buffalo. At the time of diagnosis, 4 of 10 patients presented with diabetic ketoacidosis, whereas the others had polyuria, polydipsia, and weight loss. Additionally, 9 of 10 patients had antibodies against glutamic acid decarboxylase, and 1 had autoantibodies against islet antigen 2. The mean HbA1c level was 11.7% (Standard deviation [SD], 2.1) and the fasting C-peptide level was 0.65 (SD, 0.33) ng per milliliter. At the beginning of treatment with semaglutide, all patients were receiving standard basal and prandial insulin.1
Semaglutide dosing began at a weekly dose of 0.125 mg to monitor side effects and avoid hypoglycemia. This was followed by a decrease in the dose of prandial insulin and an increase in the semaglutide dose at a maximum of 0.5 mg per week. Investigators pointed out basal insulin dosing was reduced according to data obtained from continuous glucose monitoring (CGM) and carbohydrate intake was restricted in all patients.1
At 3 months of treatment, prandial insulin use was eliminated in all patients. At 6 months, 7 of 10 patients had eliminated use of basal insulin, with these doses maintained until the end of the 12-month follow-up period.1
When assessing HbA1c, results indicated mean HbA1c decreased from 11.7% (SD, 2.1) at baseline to 5.9% (SD, 0.3) at 6 months and 5.7% (SD, 0.4) at 12 months. For fasting C-peptide levels, an increase from 0.65 (SD, 0.33) ng/mL at baseline to 1.05 (SD, 0.40) ng/mL was observed among the study cohort. Investigators also highlighted CGM data reflected a time in target glucose range of 89% (SD, 3) during the study.1
In regard to safety, investigators called attention to a report of mild hypoglycemia recorded during the increasing dose phase of the study. Following dose stabilization, no episodes of hypoglycemia were reported, according to investigators. Further analysis of safety events indicated there were no reports of diabetic ketoacidosis or other serious side effects.1
“Our findings from this admittedly small study are, nevertheless, so promising for newly diagnosed Type 1 diabetes patients that we are now absolutely focused on pursuing a larger study for a longer period of time,” Dandona added.2
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