Type2 Diabetes MellitusPhase 4HHTNNCT06449833
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
A Phase 4 study testing Henagliflozein and Metformin and Linagliptin and Metformin in people with Type2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Henagliflozein and Metformin and Linagliptin and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2024to Nov 2026
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019)
- Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)
- Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions.
- HbA1c: 7.0%-8.5%
- Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010)
Who cannot join
- Patients with type 1 diabetes, gestational diabetes or other special types of diabetes;
- Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and / or diastolic blood pressure (DBP) ≥ 100mmHg;
- Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism;
- Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment；
- Have a history of severe infection, trauma or major surgery within 3 months;
- Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence;
Show all 12Show fewer
- Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening;
- Have a history of severe anemia or need regular blood transfusion treatment;
- Have a history of any medication or treatment below:
- (1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for >1 week within 12 weeks, such as oral/intravenous glucocorticoid, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide < 25mg/d, indapamide < 1.5 mg/d) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards:
- AlanineAminotransferase(ALT)and/oraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value.
- Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula < 40mL/ (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial
This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.
- Being tested
- Henagliflozein and Metformin, Linagliptin and Metformin
- Keywords
- Type 2 Diabetes Mellitus, Nonalcoholic fatty liver disease, Hepatic Fat Content, Henagliflozein, liver function
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henagliflozein and MetforminDrug
The experimental group will be treated with 10mg Henagliflozein and Metformin.
Linagliptin and MetforminDrug
The control group will be treated with 5mg Linagliptin and Metformin.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients whose blood glucose are regulated by10 mg of Henagliflozein and metformin. Receives: Drug: Henagliflozein and Metformin |
| placebo | Placebo comparator | Patients whose blood glucose are regulated by5mg of Linagliptin and metformin. Receives: Drug: Linagliptin and Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group.
Measured: 24 weeks
Secondary outcomes (26)
The changes of liver enzymes (ALT).
Measured: 24 weeks
The changes of liver enzymes (AST).
Measured: 24 weeks
The changes of liver enzymes(GGT).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(glutathione reductase).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(total bile acid).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(fibronectin).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(N-terminal brain of type I procollagen.).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(hyaluronic acid).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(laminin).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(type IV collagen).
Measured: 24 weeks
The changes of hepatic fibrosis indexes(glycocholic acid.).
Measured: 24 weeks
Changes of visceral fat volume.
Measured: 24 weeks
Changes of subcutaneous fat volume.
Measured: 24 weeks
Changes of fasting blood glucose.
Measured: 24 weeks
Changes of fasting insulin.
Measured: 24 weeks
Changes of HbA1c.
Measured: 24 weeks
Changes of (HOMA-R).
Measured: 24 weeks
Blood lipid index(TC).
Measured: 24 weeks
Blood lipid index(TG).
Measured: 24 weeks
Blood lipid index(HDL-C).
Measured: 24 weeks
Blood lipid index(LDL-C).
Measured: 24 weeks
Changes of body weight.
Measured: 24 weeks
Changes of BMI.
Measured: 24 weeks
Changes of waist circumference.
Measured: 24 weeks
Changes of hip circumference.
Measured: 24 weeks
Changes of WHR.
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 posted10 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Chen, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449833
- Sponsor's protocol ID
- 2023LX0120_GY
- Acronym
- HHTN
- Status last verified
- Feb 2024
- First submitted
- 15 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06449833
- Acronym / sponsor ID
- HHTN / 2023LX0120_GY
- Keywords
- Type 2 Diabetes Mellitus, Nonalcoholic fatty liver disease, Hepatic Fat Content, Henagliflozein, liver function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Henagliflozein and MetforminPatients whose blood glucose are regulated by10 mg of Henagliflozein and metformin. |
| placebo | Placebo comparator | Drug: Linagliptin and MetforminPatients whose blood glucose are regulated by5mg of Linagliptin and metformin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019)
- Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)
- Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions.
- HbA1c: 7.0%-8.5%
- Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010)
Key exclusion criteria (12 listed)
- Patients with type 1 diabetes, gestational diabetes or other special types of diabetes;
- Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and / or diastolic blood pressure (DBP) ≥ 100mmHg;
- Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism;
- Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment；
- Have a history of severe infection, trauma or major surgery within 3 months;
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 |
|---|---|---|
| Henagliflozein and MetforminThe experimental group will be treated with 10mg Henagliflozein and Metformin. | Drug | intervention |
| Linagliptin and MetforminThe control group will be treated with 5mg Linagliptin and Metformin. | Drug | placebo |
Primary outcome
The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group.
Time frame: 24 weeks
26 secondary outcomes
The changes of liver enzymes (ALT).
Time frame: 24 weeks
The changes of liver enzymes (AST).
Time frame: 24 weeks
The changes of liver enzymes(GGT).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(glutathione reductase).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(total bile acid).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(fibronectin).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(N-terminal brain of type I procollagen.).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(hyaluronic acid).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(laminin).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(type IV collagen).
Time frame: 24 weeks
The changes of hepatic fibrosis indexes(glycocholic acid.).
Time frame: 24 weeks
Changes of visceral fat volume.
Time frame: 24 weeks
Changes of subcutaneous fat volume.
Time frame: 24 weeks
Changes of fasting blood glucose.
Time frame: 24 weeks
Changes of fasting insulin.
Time frame: 24 weeks
Changes of HbA1c.
Time frame: 24 weeks
Changes of (HOMA-R).
Time frame: 24 weeks
Blood lipid index(TC).
Time frame: 24 weeks
Blood lipid index(TG).
Time frame: 24 weeks
Blood lipid index(HDL-C).
Time frame: 24 weeks
Blood lipid index(LDL-C).
Time frame: 24 weeks
Changes of body weight.
Time frame: 24 weeks
Changes of BMI.
Time frame: 24 weeks
Changes of waist circumference.
Time frame: 24 weeks
Changes of hip circumference.
Time frame: 24 weeks
Changes of WHR.
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 10 Jun 2024.
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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.
Hong Chen, MD principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henagliflozein and Metformin and Linagliptin and Metformin in people with Type2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease, run by Zhujiang Hospital at 1 site 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 5 inclusion and 12 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hong Chen, MD (13602759769, rubychq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group. (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 10 Jun 2024.