Type 2 Diabetes Mellitus (T2DM)NCT06959030
An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Second Affiliated Hospital of Guangxi Medical University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- How many people
- 10,000 participants
- Where
- 7 sitesChina
- Study dates
- 19 Jun 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Chinese Patients with Type 2 Diabetes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
The People's Hospital of Beihai
Beihai, Guangxi
Hanxiao Wang
- Not yet recruiting
Guilin Municipal Hospital of Traditional Chinese Medicine
Guilin, Guangxi
Jiande Zhang
- Not yet recruiting
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Huan Xu
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Qionghua Pan
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Xinrong XIe
- Recruiting
the Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Yuzhen Liang
- Not yet recruiting
Qingdao Aikangyi Internet Hospital
Qingdao, Shandong
Yuzhen Liang Yuzhen,, 13517665676, liangyuzhen26@163.com
About this study
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.
Read more
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Observation study
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events and serious adverse events during 24 weeks of treatment
Measured: 24 weeks
Secondary outcomes (9)
changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin
Exploratory Research Objectives
Measured: 24 weeks
changes of fasting plasma glucose (FPG) in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
changes of blood pressure in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
changes of weight in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
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)
Measured: 24 weeks
changes of limb skeletal muscle mass index in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
changes of lean body mass in T2DM patients during treatment with Henagliflozin lean body mass
Measured: 24 weeks
changes of grip strength in T2DM patients during treatment with Henagliflozin
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start19 Jun 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Yuzhen, Second Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959030
- Sponsor's protocol ID
- MA-DM-Ⅳ-012
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06959030
- Acronym / sponsor ID
- MA-DM-Ⅳ-012
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese Patients with Type 2 Diabetes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortObservation study | Other | – |
Primary outcome
incidence of adverse events and serious adverse events during 24 weeks of treatment
Time frame: 24 weeks
9 secondary outcomes
changes of HbA1c (mmol/L) in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of fasting plasma glucose (FPG) in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of blood pressure in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of weight in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
incidence of specific adverse events during 24 weeks of treatment
Time frame: 24 weeks
changes of limb skeletal muscle mass index in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
changes of lean body mass in T2DM patients during treatment with Henagliflozin lean body mass
Time frame: 24 weeks
changes of grip strength in T2DM patients during treatment with Henagliflozin
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Second Affiliated Hospital of Guangxi Medical University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuzhen Liang (+8613517665676, liangyuzhen26@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events and serious adverse events during 24 weeks of treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.