Phase III, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of teneligliptin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise
| Autor: | Jingdong Liu, Jiao'e Zeng, Xinhua Xiao, Linong Ji, Xiuzhen Zhang, Wei Li, Weiping Lu, Jianhua Ma, Jialin Yang, Yi Wang, Gen Takayanagi |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male China medicine.medical_specialty Endocrinology Diabetes and Metabolism Placebo-controlled study 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Hypoglycemia Placebo Gastroenterology Diseases of the endocrine glands. Clinical endocrinology 03 medical and health sciences 0302 clinical medicine Double-Blind Method Diabetes mellitus Internal medicine Internal Medicine medicine Humans Teneligliptin Adverse effect Aged Dipeptidyl-Peptidase IV Inhibitors Dipeptidyl peptidase‐4 inhibitors Type 2 diabetes mellitus business.industry Type 2 Diabetes Mellitus Articles General Medicine Middle Aged RC648-665 medicine.disease Clinical Trial Clinical trial Clinical Science and Care Diabetes Mellitus Type 2 Pyrazoles Thiazolidines Female business medicine.drug |
| Zdroj: | Journal of Diabetes Investigation Journal of Diabetes Investigation, Vol 12, Iss 4, Pp 537-545 (2021) |
| ISSN: | 2040-1124 2040-1116 |
| DOI: | 10.1111/jdi.13389 |
| Popis: | Aims/Introduction Although the efficacy of teneligliptin, a highly selective dipeptidyl peptidase‐4 inhibitor, has been amply studied for the treatment of type 2 diabetes, no clinical trials of teneligliptin have been carried out in China. We evaluated the efficacy and safety of teneligliptin monotherapy compared with a placebo in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Materials and Methods This multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study, carried out at 42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin 7.0 to This multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study evaluated the efficacy and safety of teneligliptin monotherapy compared with a placebo in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. To assess efficacy (primary efficacy end‐point: glycosylated hemoglobin from baseline to week 24) and safety (incidence of adverse events and adverse drug reactions), eligible type 2 diabetes patients were assigned in a 1:1 ratio to treatment with teneligliptin 20 mg or a placebo, administered orally once daily before breakfast for 24 weeks. The least square mean change in glycosylated hemoglobin from baseline to week 24 was −0.95% with teneligliptin versus −0.14% with a placebo, and the least square mean change in fasting plasma glucose from baseline to week 24 was −21.9 mg/dL with teneligliptin versus −1.4 mg/dL with a placebo, with the incidence rates of adverse events and adverse drug reactions being similar in both groups, showing that teneligliptin was effective and generally well tolerated at 24 weeks among Chinese patients with type 2 diabetes inadequately controlled with diet and exercise. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|