An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients with Type 2 Diabetes Primary Research Objective • To evaluate the safety of Henagliflozin in Chinese patients with type 2 diabetes mellitus (T2DM) in real world. Exploratory Research Objectives * 1\. Improvement in metabolic parameters: To assess changes in metabolic indicators, including glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), blood pressure, and body weight, in T2DM patients treated with Henagliflozin. * 2\. Incidence of specific adverse events: To investigate the occurrence of key adverse events, with a focus on hypovolemia, amputation or amputation risk, fractures, urinary tract infections, genital infections, renal impairment, diabetic ketoacidosis, hepatic dysfunction, and severe hypoglycemia. * 3\. Impact on muscle health: To evaluate changes in muscle health indicators, such as skeletal muscle mass index, lean body mass, and grip strength, in T2DM patients receiving Henagliflozin therapy.
Study Type
OBSERVATIONAL
Enrollment
10,000
Observation study
The People's Hospital of Beihai
Beihai, Guangxi, China
NOT_YET_RECRUITINGGuilin Municipal Hospital of Traditional Chinese Medicine
Guilin, Guangxi, China
NOT_YET_RECRUITINGNanxishan Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
NOT_YET_RECRUITINGthe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGQingdao Aikangyi Internet Hospital
Qingdao, Shandong, China
NOT_YET_RECRUITINGincidence of adverse events and serious adverse events during 24 weeks of treatment
Time frame: 24 weeks
changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin
Exploratory Research Objectives
Time frame: 24 weeks
changes of fasting plasma glucose (FPG) in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of blood pressure in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of weight in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
incidence of specific adverse events during 24 weeks of treatment
specific adverse events (including abnormal liver function test, urinary tract infection, genital infection, hypovolemia, renal events, serious hypoglycemia events, fractures, diabetic ketoacidosis, amputation caused by adverse events or with amputation risk)
Time frame: 24 weeks
changes of limb skeletal muscle mass index in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of lean body mass in T2DM patients during treatment with Henagliflozin lean body mass
Time frame: 24 weeks
changes of grip strength in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
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