Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double‐blind, placebo‐controlled study
| Autor: | Weiping Lu, Jianhua Ma, Dongmei Li, Jiao Sun, Xuefeng Li, Bangzhu Meng, Yanmei Liu, Ling Li, Gen Takayanagi, Yi Wang, Linong Ji |
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| Rok vydání: | 2021 |
| Předmět: |
Blood Glucose
medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Placebo-controlled study Glycemic Control Type 2 diabetes Placebo lcsh:Diseases of the endocrine glands. Clinical endocrinology Gastroenterology Placebos Asian People Double-Blind Method Original Research Articles Internal medicine Diabetes mellitus medicine Humans Original Research Article Teneligliptin Adverse effect dipeptidyl peptidase‐IV inhibitors Glycated Hemoglobin lcsh:RC648-665 business.industry nutritional and metabolic diseases Type 2 Diabetes Mellitus Fasting medicine.disease Metformin Treatment Outcome type 2 Diabetes Mellitus Type 2 diabetes mellitus Pyrazoles Thiazolidines Drug Therapy Combination Safety business Biomarkers medicine.drug |
| Zdroj: | Endocrinology, Diabetes & Metabolism Endocrinology, Diabetes & Metabolism, Vol 4, Iss 2, Pp n/a-n/a (2021) |
| ISSN: | 2398-9238 |
| DOI: | 10.1002/edm2.222 |
| Popis: | Introduction We evaluated the efficacy and safety of teneligliptin compared with placebo when added to metformin therapy in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy. Methods This multicentre, randomized, double‐blind, placebo‐controlled, parallel‐group study enrolled type 2 diabetes patients with glycosylated haemoglobin (HbA1c) 7.0%− In this multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study, we evaluated the efficacy and safety of teneligliptin compared with placebo when added to metformin therapy in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy. Eligible type 2 diabetes patients receiving a stable metformin dose ≥1000 mg/day received teneligliptin 20 mg or placebo orally once daily (qd) before breakfast for 24 weeks to assess the primary efficacy end‐point (change in HbA1c from baseline to Week 24) and safety (including the incidence of adverse events). The least square mean (LSM) change from baseline (standard error [SE]) was −0.72 (0.07) for teneligliptin and −0.01 (0.07) for placebo, and the differences (LSM ± SE) between the placebo and teneligliptin groups in HbA1c and FPG were −0.71% ± 0.11% and −16.5 ± 4.7 mg/dl, with similar treatment‐emergent AE incidences in both groups, indicating that teneligliptin 20 mg qd for 24 weeks added to ongoing metformin treatment was safe and tolerable, and significantly decreased HbA1c and FPG levels compared with placebo in Chinese type 2 diabetes patients. |
| Databáze: | OpenAIRE |
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