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

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 Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Other: No Intervention: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yuzhen Liang; Phone Number: +8613517665676; Email: liangyuzhen26@163.com

Study Locations

• China
  • Guangxi
    • Beihai, Guangxi, China
      • Not yet recruiting
      • The People's Hospital of Beihai
      • Contact: Hanxiao Wang
    • Guilin, Guangxi, China
      • Not yet recruiting
      • Guilin Municipal Hospital of Traditional Chinese Medicine
      • Contact: Jiande Zhang
    • Nanning, Guangxi, China
      • Not yet recruiting
      • The People's Hospital of Guangxi Zhuang Autonomous Region
      • Contact: Xinrong XIe
    • Nanning, Guangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Guangxi Medical University
      • Contact: Yuzhen Liang
    • Nanning, Guangxi, China
      • Not yet recruiting
      • Nanxishan Hospital of Guangxi Zhuang Autonomous Region
      • Contact: Huan Xu
  • Shandong
    • Qingdao, Shandong, China
      • Not yet recruiting
      • Qingdao Aikangyi Internet Hospital
      • Contact: Yuzhen Liang Yuzhen,; Phone Number: 13517665676; Email: liangyuzhen26@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Chinese Patients with Type 2 Diabetes

Description

Inclusion Criteria:

1. 18 years old≤ age ≤ 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of adverse events and serious adverse events during 24 weeks of treatment	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 weeks
changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin	Exploratory Research Objectives	24 weeks
changes of fasting plasma glucose (FPG) in T2DM patients during treatment with Henagliflozin		24 weeks
changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with Henagliflozin		24 weeks
changes of blood pressure in T2DM patients during treatment with Henagliflozin		24 weeks
changes of weight in T2DM patients during treatment with Henagliflozin		24 weeks
changes of limb skeletal muscle mass index in T2DM patients during treatment with Henagliflozin		24 weeks
changes of lean body mass in T2DM patients during treatment with Henagliflozin lean body mass		24 weeks
changes of grip strength in T2DM patients during treatment with Henagliflozin		24 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: MA-DM-Ⅳ-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No