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Exenatide extended release in patients with type 1 diabetes with and without residual insulin production.

Citation
Herold, K. C., et al. “Exenatide Extended Release In Patients With Type 1 Diabetes With And Without Residual Insulin Production.”. Diabetes, Obesity & Metabolism, pp. 2045-2054.
Center Joslin Diabetes Center Yale University
Multicenter
Multicenter
Author Kevan C Herold, Jesse Reynolds, James Dziura, David Baidal, Jason Gaglia, Stephen E Gitelman, Peter A Gottlieb, Jennifer Marks, Louis H Philipson, Rodica Pop-Busui, Ruth S Weinstock
Keywords C-peptide, adjunctive therapy, glucagon-like peptide-1 receptor agonist, type 1 diabetes
Abstract

AIMS: To test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function.

METHODS: We performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug.

RESULTS: At week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P <0.001 and P = 0.007). The total insulin dose was lower, but not when corrected for body weight, and was not affected by residual insulin production. Adverse events were more frequent with exenatide ER, but hypoglycaemia was not increased.

CONCLUSION: Treatment with exenatide ER may have short-term benefits in some individuals with T1D who are overweight or who have detectable levels of C-peptide, but short-term improvements were not sustained.

Year of Publication
2020
Journal
Diabetes, obesity & metabolism
Volume
22
Issue
11
Number of Pages
2045-2054
Date Published
11/2020
ISSN Number
1463-1326
DOI
10.1111/dom.14121
Alternate Journal
Diabetes Obes Metab
PMID
32573927
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