NCT06959030

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2025Sep 2026

First Submitted

Initial submission to the registry

April 16, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 8, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

April 16, 2025

Last Update Submit

July 2, 2025

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

  • incidence of adverse events and serious adverse events during 24 weeks of treatment

    24 weeks

Secondary Outcomes (9)

  • changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin

    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

  • +4 more secondary outcomes

Interventions

No Intervention: Observational CohortOTHER

Observation study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese Patients with Type 2 Diabetes

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The People's Hospital of Beihai

Beihai, Guangxi, China

NOT YET RECRUITING

Guilin Municipal Hospital of Traditional Chinese Medicine

Guilin, Guangxi, China

NOT YET RECRUITING

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

the Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Qingdao Aikangyi Internet Hospital

Qingdao, Shandong, China

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Yuzhen Liang

CONTACT

+8613517665676liangyuzhen26@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endocrinology Department, chief physician, MD, doctoral supervisor

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 6, 2025

Study Start

June 19, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)