Long-term safety and efficacy of fasiglifam (TAK-875), a G-protein-coupled receptor 40 agonist, as monotherapy and combination therapy in Japanese patients with type 2 diabetes: a 52-week open-label phase III study
| Autor: | R. Nakaya, R. Matsuno, T. Ohira, Kazuaki Enya, Kohei Kaku |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Agonist Blood Glucose Male Combination therapy medicine.drug_class Endocrinology Diabetes and Metabolism medicine.medical_treatment Biguanides Type 2 diabetes Pharmacology Receptors G-Protein-Coupled 03 medical and health sciences 0302 clinical medicine Endocrinology Japan Internal Medicine Medicine Humans Glycoside Hydrolase Inhibitors Sulfones Thiazolidinedione Adverse effect Benzofurans Glycated Hemoglobin Dipeptidyl-Peptidase IV Inhibitors business.industry Biguanide Insulin Type 2 Diabetes Mellitus Middle Aged medicine.disease Hypoglycemia 030104 developmental biology Sulfonylurea Compounds Treatment Outcome Diabetes Mellitus Type 2 Liver Drug Therapy Combination Female Thiazolidinediones business 030217 neurology & neurosurgery |
| Zdroj: | Diabetes, obesitymetabolism. 18(9) |
| ISSN: | 1463-1326 |
| Popis: | This multicentre, open-label, phase III study investigated the safety and efficacy of the G-protein-coupled receptor 40 agonist fasiglifam. Japanese patients with type 2 diabetes and inadequate glycaemic control despite diet and/or exercise (n = 282), or despite diet and/or exercise plus one oral antidiabetic agent [sulphonylurea (n = 262), rapid-acting insulin secretagogue (n = 124), α-glucosidase inhibitor (n = 141), biguanide (n = 136), thiazolidinedione (n = 139) or dipeptidyl peptidase-4 inhibitor (n = 138)] were randomized to treatment with fasiglifam 25 or 50 mg once daily for 52 weeks. The primary endpoints were safety variables. The overall incidence of treatment-emergent adverse events (TEAEs) was 75.4-85.1% in the 25 mg group and 78.9-89.9% in the 50 mg group; most TEAEs were mild. Hypoglycaemia was negligible with fasiglifam monotherapy and most common with sulphonylurea combination therapy (12.4 and 9.1% for 25 and 50 mg groups, respectively). Abnormal liver-related laboratory values were uncommon. Glycated haemoglobin levels decreased from week 2 in all groups and were maintained to week 52. Although fasiglifam as monotherapy or in combination regimens was well tolerated during long-term treatment, global concerns about liver safety led to termination of its development after study completion. |
| Databáze: | OpenAIRE |
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