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

Autor: Kevan C. Herold, Peter A. Gottlieb, Louis H. Philipson, James Dziura, David A. Baidal, Ruth S. Weinstock, Jason L. Gaglia, Rodica Pop-Busui, Jennifer B. Marks, Stephen E. Gitelman, Jesse Reynolds
Rok vydání: 2020
Předmět:
Glycated Hemoglobin A
type 1 diabetes
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
030204 cardiovascular system & hematology
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Endocrinology
Insulin
Pediatric
C-peptide
Diabetes
5.1 Pharmaceuticals
6.1 Pharmaceuticals
Development of treatments and therapeutic interventions
Type 2
Type 1
medicine.drug
medicine.medical_specialty
adjunctive therapy
glucagon-like peptide-1 receptor agonist
Clinical Trials and Supportive Activities
Clinical Sciences
030209 endocrinology & metabolism
Placebo
Article
Endocrinology & Metabolism
03 medical and health sciences
Clinical Research
Internal medicine
Diabetes Mellitus
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Adverse effect
Metabolic and endocrine
Glucagon-like peptide 1 receptor
Glycated Hemoglobin
Type 1 diabetes
Venoms
business.industry
Evaluation of treatments and therapeutic interventions
medicine.disease
Confidence interval
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2
chemistry
Exenatide
business
Zdroj: Diabetes, obesity & metabolism, vol 22, iss 11
Diabetes Obes Metab
ISSN: 1463-1326
1462-8902
DOI: 10.1111/dom.14121
Popis: 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
Databáze: OpenAIRE
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