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PreDiabetesPhase 4NCT06448130

Henagliflozin's Impact on Prediabetes Remission

A Phase 4 study testing Henagliflozin 5mg and Henagliflozin 10mg in people with PreDiabetes and Prediabetic State, run by Shandong Provincial Hospital at 50 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PreDiabetes, Prediabetic State, Type 2 Diabetes
What is being tested?
Henagliflozin 5mg and Henagliflozin 10mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
984 participants
Where
50 sitesChina
Study dates
Jun 2024to Dec 2027
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects between the ages of 18 and 65 years;
  • Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;
  • Prediabetic patients as defined by Expert Consensus on Intervention for Prediabetes in Chinese Adults, 2023 Edition:1)Fasting plasma glucose (FPG) between 6.1 and 7.0 mmol/L and/or 2-hour postprandial glucose (2h-PPG) between 7.8 and 11.1 mmol/L; 2)And/or HbA1c between 5.7% and 6.5%;
  • Individuals willing to provide written informed consent and can comply with study procedures and follow-up.

Who cannot join

  • Allergic to Henagliflozin;
  • Previously diagnosed with diabetes;
  • HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L;
  • Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;
  • Fluctuation in weight by 5% or more in the past month;
  • Use of drugs affecting glucose synthesis, absorption, or metabolism, such as glucocorticoids (e.g., prednisone, dexamethasone), contraceptives, growth hormone, hormonal replacement therapy (estrogen and progesterone), immunosuppressants (e.g., cyclosporine A, tacrolimus), anti-tuberculosis drugs (e.g., isoniazid, rifampicin);
Show all 18Show fewer
  • Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;
  • Persistently uncontrolled hypertension (used antihypertensive drugs but was not effectively controlled in the 3 months prior to enrollment) or currently use 3 or more antihypertensive drugs (including diuretics);
  • Assessed by the investigator to be at high risk of genitourinary system infections, such as history of recurrent urinary tract infections or reproductive system infections, long-term placement of urinary catheters, or history of urological surgery;
  • Other obesity caused by endocrine disorders, such as Cushing's syndrome;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3 times of the upper limit of the normal range (UNL);
  • eGFR less than 30 mL/min/1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;
  • Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;
  • Impaired consciousness and various mental health disorders;
  • Malignant tumors and other serious illnesses;
  • Pregnant or breast-feeding or planning pregnancy within 24 months;
  • Enrolled in another clinical trial currently or within the 3 months prior to enrollment;
  • Identified by the investigator that lacks sufficient motivation to continue the long-term clinical trial (e.g., out-of-town study, work plan, need to care for family members), or considered prefer to withdraw from the trial for non-medical reasons (such as social issues).

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiude Fan, MD&PhD contact

+8613186067538

fanxiudexjtu@163.com

Junming Han, PhD contact

+8615610140319

hanjunming@sdfmu.edu.cn

50 sites in 1 country

China50 sites

  • The Second Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014000

  • Beijing Hospital

    Beijing, 100000

  • Beijing Luhe Hospital

    Beijing, 100000

    Dong Zhao, MD, +8618911598827

  • Beijing Chao Yang Hospital

    Beijing, 100005

  • Binzhou City Central Hospital

    Binzhou, Shandong, 256600

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400000

  • Chuzhou First People's Hospital

    Chuzhou, Anhui, 239000

  • Dongying People's Hospital

    Dongying, Shandong, 257000

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong, 528000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350000

  • Southern Medical University

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guanzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui, 230000

  • Jinan Central Hospital

    Jinan, Shandong, 250000

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021

    Xiude Fan, +8613186067538, fanxiudexjtu@163.com

    Jiajun Zhao

  • LanZhou University

    Lanzhou, Gansu, 730000

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • The Central Hospital of Lishui City

    Lishui, Zhejiang, 323000

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangsu, 330299

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital with Nanjing Medical University,

    Nanjing, Jiangsu, 210000

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

  • Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, 200000

  • Shanghai 10th People's Hospital

    Shanghai, 200000

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, 200000

  • First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110000

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271000

  • North China University of Technology Affiliated Hospital

    Tangshan, Hebei, 063000

  • Peking University Binhai Hospital

    Tianjin, 300000

  • Tianjin First Central Hospital

    Tianjin, 300000

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The Affiliated Hospital of Weifang Medical University

    Weifang, Shandong, 261000

  • Weifang People's Hospital

    Weifang, Shandong, 261000

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital

    Wuhan, Hubei, 430000

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214000

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441100

  • Xinyang Central Hospital

    Xinyang, Henan, 464000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Yantai Affiliated Hospital of Binzhou Medical University

    Yantai, Shandong, 264000

  • Ningxia Medical University

    Yinchuan, Ningxia, 750000

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Gaofei Ren, MD, +8615890688469

Other trials in China

About this study

Official title: Effect of Henagliflozin on the Remission of Prediabetes Population: A National Multicenter, Randomized Controlled Study

This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Henagliflozin, a novel SGLT2 inhibitor developed in China, aims to improve glucose control and metabolic health when paired with lifestyle changes.

The study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment.

Read more

The trial will compare three groups (Henagliflozin 5mg, 10mg, and a placebo), focusing on efficacy and safety. Participants, assigned randomly, will undergo a 6-month treatment phase and an 18-month follow-up. Regular health assessments will monitor glucose levels, metabolic health, and risks of major complications like cardiovascular events and microvascular diseases, with additional evaluations of C-peptide and insulin changes.

Structured as a multicenter, randomized, double-blind, placebo-controlled study, it involves 984 prediabetic adults across 50 medical institutions in China. This comprehensive approach could redefine prediabetes management by integrating drug therapy with lifestyle modifications.

Read the detailed description

This research is launched in light of the global surge in prediabetes, a condition that markedly increases the risk of developing type 2 diabetes and related vascular complications. While lifestyle modifications are the frontline defense against prediabetes, the variability in individual responses often requires the integration of pharmacological treatments. Studies have shown that drugs such as metformin, acarbose, SGLT2 inhibitors, GLP-1 agonists, GIP/GLP-1 receptor agonists, thiazolidinediones, and orlistat effectively curb the progression to diabetes. Yet, there remains a gap in specific research addressing the intervention needs of the prediabetic population in China.

Currently, acarbose is the only drug approved in the Chinese market for treating patients with impaired glucose tolerance, highlighting a limited range of therapeutic options for prediabetes. SGLT2 inhibitors, as a newer class of hypoglycemic agents, have demonstrated significant promise in reducing major cardiovascular events in high-risk patients with type 2 diabetes, enhancing outcomes in heart failure, and providing renal protection. However, there is a scarcity of large-scale, prospective studies on the impact of SGLT2 inhibitors in prediabetes. Henagliflozin, the first original SGLT2 inhibitor developed in China and launched on December 31, 2021, is being studied to assess its effectiveness combined with lifestyle interventions in the prediabetic demographic, aiming to fill a crucial void in the current treatment paradigm.

This study aims to assess the combined benefits of Henagliflozin and lifestyle modifications in managing prediabetes. The investigators conducted a two-year prospective, randomized, double-blind, placebo-controlled trial across 50 medical institutions in various provinces of China. It is planned to enroll 984 adult prediabetic patients who had not previously been treated with antidiabetic medications. Participants meeting inclusion criteria were randomly assigned to one of three groups: Henagliflozin 5mg, Henagliflozin 10mg, or placebo. The intensive intervention phase, consisting of pharmacotherapy combined with lifestyle changes, lasted for 6 months, followed by an 18-month follow-up period focusing solely on lifestyle interventions.

The primary endpoint is the proportion of participants achieving normoglycemia after 6 months of intervention, with subsequent assessments at 12 months. Secondary endpoints include short-term (0-12 months) and long-term (12-24 months) changes in glucose control, metabolic indicators such as body weight, body mass index (BMI), body fat content, waist and hip circumference, lipid profiles, blood pressure, serum uric acid levels, hepatic steatosis, and carotid intima-media thickness. Exploratory outcomes encompass changes in C-peptide and insulin levels from baseline to 6 months, and the risk of major adverse cardiovascular events (MACE) from baseline to 24 months and beyond.

Being tested
Henagliflozin 5mg, Henagliflozin 10mg, Placebo
Keywords
Prediabetes management, Henagliflozin, SGLT2 inhibitors, Lifestyle interventions, Type 2 diabetes prevention, Glucose Metabolism Disorders, Metabolic Diseases
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Henagliflozin 5mgDrug

    Also called lifestyle intervention

    Henagliflozin 5mg + lifestyle intervention

  • Henagliflozin 10mgDrug

    Also called lifestyle intervention

    Henagliflozin 10mg+ lifestyle intervention

  • PlaceboDrug

    Also called lifestyle intervention

    Placebo+ lifestyle intervention

Study groups in NCT06448130
Study groupRoleWhat they receive
Henagliflozin5mg + lifestyle interventionExperimentalHenagliflozin 5mg+ placebo 10mg po qd + lifestyle intervention for 6 months
Receives: Drug: Henagliflozin 5mg
Henagliflozin10mg+ lifestyle interventionExperimentalHenagliflozin 10mg+ placebo 5mg po qd + lifestyle intervention for 6 months
Receives: Drug: Henagliflozin 10mg
placebo+ lifestyle interventionPlacebo comparatorplacebo 10mg + placebo 5mg po qd + lifestyle intervention for 6 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Normoglycemia Achievement Rates Post-6-Month Intervention

    This measure assesses the proportion of participants who achieve normoglycemia from the end of a 6-month intervention until the 12-month assessment point. Normoglycemia is defined as fasting plasma glucose (FPG) less than 6.1 mmol/L and 2-hour post-prandial glucose (2h-PPG) less than 7.8 mmol/L. The measure includes rates of sustained remission (normal glycemic status lasting more than 6 months post-medication cessation), partial remission (lasting 3-6 months), and temporary remission (lasting less than 3 months).

    Measured: From 6 months post-intervention to 12 months

Secondary outcomes (22)

  1. Blood Glucose Control Normalization

    Proportion and duration of normalization of blood glucose levels within 24 months in the three study groups.

    Measured: From 6 months post-intervention to 24 months

  2. Incidence of New-Onset Type 2 Diabetes

    Incidence of new-onset type 2 diabetes within 24 months in the three study groups.

    Measured: From 0 to 24 months

  3. Changes in HbA1c Levels

    Changes in HbA1c levels over the 24-month period in the three study groups.

    Measured: From 0 to 24 months

  4. Impact of Glycemic Status at 12 Months

    Impact of glycemic status at 12 months on subsequent reversal to normoglycemia and risk of new-onset type 2 diabetes during the 12-24 month follow-up period in the three study groups.

    Measured: From 12 months to 24 months

  5. Changes in blood pressure over 24 Months

    Changes in systolic and diastolic blood pressure in the three study groups over 24 Months.

    Measured: From 0 to 24 months

  6. Changes in serum uric acid levels over 24 Months

    Changes in serum uric acid levels in the three study groups over 24 Months.

    Measured: From 0 to 24 months

  7. Changes in hepatic steatosis over 24 Months

    Changes in hepatic steatosis assessed by abdominal ultrasound in the three study groups over 24 Months.

    Measured: From 0 to 24 months

  8. Changes in carotid intima-media thickness over 24 Months

    Changes in carotid intima-media thickness measured by carotid ultrasound in the three study groups over 24 Months.

    Measured: From 0 to 24 months

  9. Changes in Total Cholesterol (TC) over 24 Months

    Measurement of Total Cholesterol (TC) levels in millimoles per liter (mmol/L) using standardized laboratory procedures. Fasting blood samples will be collected at multiple time points within the 24-month period to assess changes over time.

    Measured: From 0 to 24 months

  10. Changes in Triglycerides (TG) over 24 Months

    Measurement of Triglycerides (TG) levels in millimoles per liter (mmol/L) using standardized laboratory procedures. Fasting blood samples will be collected at multiple time points within the 24-month period to assess changes over time.

    Measured: From 0 to 24 months

  11. Changes in Low-Density Lipoprotein Cholesterol (LDL-c) over 24 Month

    Measurement of Low-Density Lipoprotein Cholesterol (LDL-c) levels in millimoles per liter (mmol/L) using standardized laboratory procedures. Fasting blood samples will be collected at multiple time points within the 24-month period to assess changes over time.

    Measured: From 0 to 24 months

  12. Changes in High-Density Lipoprotein Cholesterol (HDL-c) over 24 Months

    Measurement of High-Density Lipoprotein Cholesterol (HDL-c) levels in millimoles per liter (mmol/L) using standardized laboratory procedures. Fasting blood samples will be collected at multiple time points within the 24-month period to assess changes over time.

    Measured: From 0 to 24 months

  13. Changes in Body Weight over 24 Months

    Measurement of body weight in kilograms (kg) at multiple time points within the 24-month period.

    Measured: From 0 to 24 months

  14. Changes in Body Mass Index (BMI) over 24 Months

    Calculation of BMI in kg/m² using the formula: weight (kg) / (height (m)²), measured at multiple time points within the 24-month period.

    Measured: From 0 to 24 months

  15. Changes in Body Fat Content over 24 Months

    Measurement of body fat content as a percentage (%) of total body weight at multiple time points within the 24-month period.

    Measured: From 0 to 24 months

  16. Changes in Waist Circumference over 24 Months

    Measurement of waist circumference in centimeters (cm) at multiple time points within the 24-month period.

    Measured: From 0 to 24 months

  17. Changes in Hip Circumference over 24 Months

    Measurement of hip circumference in centimeters (cm) at multiple time points within the 24-month period.

    Measured: From 0 to 24 months

  18. Changes in C-peptide Levels over the First 6 Months

    Measurement of C-peptide levels in nanomoles per liter (nmol/L) at multiple time points within the 6-month period.

    Measured: From 0 to 6 months

  19. Changes in Insulin Levels over the First 6 Months

    Measurement of insulin levels in milliunits per liter (mU/L) at multiple time points within the 6-month period.

    Measured: From 0 to 6 months

  20. Major Adverse Cardiovascular Events

    Major Adverse Cardiovascular Events (MACE) in the three study groups over 0-24 months.

    Measured: From 0 to 24 months

  21. Risk of Retinal Diseases

    Risk of retinal diseases (e.g., diabetic retinopathy) in the three study groups over 0-24 months.

    Measured: From 0 to 24 months

  22. Risk of Renal diseases

    Risk of renal diseases (e.g., diabetic nephropathy/chronic kidney disease) in the three study groups over 0-24 months.

    Measured: From 0 to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
984 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06448130
Sponsor's protocol ID
MA-DM-IV-004
Status last verified
Jun 2024
First submitted
15 May 2024
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We have opted for 'Undecided' regarding the sharing of individual participant data (IPD) at this stage. Our decision is pending as we are currently engaged in ongoing discussions and evaluations regarding the most appropriate approach to IPD sharing for our research. Factors such as ethical considerations, data sensitivity, and regulatory requirements are being carefully assessed. We aim to reach a well-informed decision in due course and will update our IPD sharing plan accordingly. Thank you for your understanding as we navigate through this process.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Henagliflozin 5mg and Henagliflozin 10mg in people with PreDiabetes and Prediabetic State, run by Shandong Provincial Hospital at 50 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 4 inclusion and 18 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: opening soon, as of the sponsor's last update on 7 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 50 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. 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 Xiude Fan, MD&PhD (+8613186067538, fanxiudexjtu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Normoglycemia Achievement Rates Post-6-Month Intervention (time frame: From 6 months post-intervention to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06448130.

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 7 Jun 2024.

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