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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-19

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No Intervention: Observational Cohort

Observation study

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liang Yuzhen

Director of Endocrinology Department, chief physician, MD, doctoral supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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