Efficacy and safety of once‐monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo‐controlled, 16‐week randomized dose‐finding study
| Autor: | Michael Derwahl, Kun-Ho Yoon, Michael E. Trautmann, Stefano Del Prato, Jahoon Kang, Christopher H. Sorli, John Stewart, Alfonso Soto |
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| Rok vydání: | 2020 |
| Předmět: |
Agonist
medicine.medical_specialty Proline medicine.drug_class Endocrinology Diabetes and Metabolism Glucagon-Like Peptides phase I‐II study 030209 endocrinology & metabolism dose–response relationship GLP-1 analogue incretin phase I-II study type 2 diabetes (T2D) Type 2 diabetes 030204 cardiovascular system & hematology Placebo Gastroenterology 03 medical and health sciences 0302 clinical medicine Endocrinology Double-Blind Method GLP‐1 analogue Weight loss Internal medicine Internal Medicine medicine Clinical endpoint Humans Hypoglycemic Agents In patient Adverse effect Glycated Hemoglobin business.industry Original Articles medicine.disease Metformin Treatment Outcome Diabetes Mellitus Type 2 Drug Therapy Combination Original Article medicine.symptom business medicine.drug |
| Zdroj: | Diabetes, Obesity & Metabolism |
| ISSN: | 1463-1326 1462-8902 |
| DOI: | 10.1111/dom.14020 |
| Popis: | Aims To determine the optimal dose(s) of once‐monthly administration of efpeglenatide, a long‐acting glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in patients with type 2 diabetes (T2D) inadequately controlled on metformin. Materials and methods In this phase 2, randomized, placebo‐controlled, double‐blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51). The 16‐week treatment period included a 4‐week titration phase with once‐weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once‐monthly dose. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 17. Results All efpeglenatide doses significantly reduced HbA1c versus placebo (P |
| Databáze: | OpenAIRE |
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