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An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes

Recruitingn/aAges 18 Years - 80 YearsAllSecond Affiliated Hospital of Guangxi Medical Uniโ€ฆ
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In plain words

What the trial is, and whether it could suit you

An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients with Type 2 Diabetes Primary Research Objective โ€ข 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 evalua

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 18 years oldโ‰ค age โ‰ค 80 years old; 2. Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, currently receiving or eligible for add-on therapy with Henagliflozin; 3. Voluntarily participate in this study and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form. Exclusion Criteria: 1. Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study. 2. Current or history of recurrent urinary tract infections (UTIs) and/or genital infections. 3. Patients judged by the investigator to be unsuitable to participate in this clinical trial, with considerations such as current blood volume status, estimated glomerular filtration rate (eGFR), and other clinical parameters.
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What it tests

  • No Intervention: Observational Cohort
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Where

7 sites
The People's Hospital of Beihai
Beihai, China
Guilin Municipal Hospital of Traditional Chinese Medicine
Guilin, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
the Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Qingdao Aikangyi Internet Hospital
Qingdao, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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