Status:

RECRUITING

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

Lead Sponsor:

Second Affiliated Hospital of Guangxi Medical University

Conditions:

Type 2 Diabetes Mellitus (T2DM)

Eligibility:

All Genders

18-80 years

Brief Summary

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 wi...

Eligibility Criteria

Inclusion

  • 18 years old≤ age ≤ 80 years old;
  • Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, currently receiving or eligible for add-on therapy with Henagliflozin;
  • 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

  • Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study.
  • Current or history of recurrent urinary tract infections (UTIs) and/or genital infections.
  • 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.

Key Trial Info

Start Date :

June 19 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

10000 Patients enrolled

Trial Details

Trial ID

NCT06959030

Start Date

June 19 2025

End Date

September 1 2026

Last Update

July 8 2025

Active Locations (7)

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Page 1 of 2 (7 locations)

1

The People's Hospital of Beihai

Beihai, Guangxi, China

2

Guilin Municipal Hospital of Traditional Chinese Medicine

Guilin, Guangxi, China

3

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

4

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China