Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus
Autor: | De-zhong Wang, Kun Wang, Li Chen, Jing Yang, Qiu Chen, Minxiang Lei, Hai-fang Wang, Pei-feng Xie, Bin-hong Duan, Wan-shou Tan, Qiu Zhang, Jian Guo, Lixin Guo, Guo-en Liu, Wei Zhu, Xian-ling Zheng, Quan-zhong Li |
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Rok vydání: | 2021 |
Předmět: |
Adult
Blood Glucose medicine.medical_specialty endocrine system diseases type 2 diabetes mellitus Endocrinology Diabetes and Metabolism Gastroenterology Diseases of the endocrine glands. Clinical endocrinology chemistry.chemical_compound Endocrinology Weight loss Internal medicine Diabetes mellitus medicine Humans Hypoglycemic Agents Glucophage Aged Original Research Glycated Hemoglobin diabetes business.industry Incidence (epidemiology) nutritional and metabolic diseases Type 2 Diabetes Mellitus Middle Aged RC648-665 medicine.disease Metformin metformin hydrochloride sustained-release Dulening Clinical trial Treatment Outcome Diabetes Mellitus Type 2 chemistry Delayed-Action Preparations Glycated hemoglobin medicine.symptom business Tablets medicine.drug |
Zdroj: | Frontiers in Endocrinology Frontiers in Endocrinology, Vol 12 (2021) |
ISSN: | 1664-2392 |
Popis: | ObjectivesThis study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).MethodsThis randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.ResultsThere were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.ConclusionsMetformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets. |
Databáze: | OpenAIRE |
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