Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
984 participants
INTERVENTIONAL
2024-06-30
2027-12-31
Brief Summary
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The study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment.
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Henagliflozin5mg + lifestyle intervention
Henagliflozin 5mg+ placebo 10mg po qd + lifestyle intervention for 6 months
Henagliflozin 5mg
Henagliflozin 5mg + lifestyle intervention
Henagliflozin10mg+ lifestyle intervention
Henagliflozin 10mg+ placebo 5mg po qd + lifestyle intervention for 6 months
Henagliflozin 10mg
Henagliflozin 10mg+ lifestyle intervention
placebo+ lifestyle intervention
placebo 10mg + placebo 5mg po qd + lifestyle intervention for 6 months
Placebo
Placebo+ lifestyle intervention
Interventions
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Henagliflozin 5mg
Henagliflozin 5mg + lifestyle intervention
Henagliflozin 10mg
Henagliflozin 10mg+ lifestyle intervention
Placebo
Placebo+ lifestyle intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;
3. 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%;
4. Individuals willing to provide written informed consent and can comply with study procedures and follow-up.
Exclusion Criteria
2. Previously diagnosed with diabetes;
3. HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L;
4. Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;
5. Fluctuation in weight by 5% or more in the past month;
6. 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);
7. Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;
8. 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);
9. 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;
10. Other obesity caused by endocrine disorders, such as Cushing's syndrome;
11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3 times of the upper limit of the normal range (UNL);
12. eGFR less than 30 mL/min/1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;
13. Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;
14. Impaired consciousness and various mental health disorders;
15. Malignant tumors and other serious illnesses;
16. Pregnant or breast-feeding or planning pregnancy within 24 months;
17. Enrolled in another clinical trial currently or within the 3 months prior to enrollment;
18. 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).
18 Years
65 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Jia-jun Zhao
Principal Investigator
Locations
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Chuzhou First People's Hospital
Chuzhou, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
LanZhou University
Lanzhou, Gansu, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
North China University of Technology Affiliated Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Xinyang Central Hospital
Xinyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University,
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Ningxia Medical University
Yinchuan, Ningxia, China
Binzhou City Central Hospital
Binzhou, Shandong, China
Dongying People's Hospital
Dongying, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, China
The Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Central Hospital of Lishui City
Lishui, Zhejiang, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Beijing Luhe Hospital
Beijing, , China
Beijing Chao Yang Hospital
Beijing, , China
First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Baoshan Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, , China
Shanghai 10th People's Hospital
Shanghai, , China
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, , China
Peking University Binhai Hospital
Tianjin, , China
Tianjin First Central Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Gaofei Ren, MD
Role: primary
Dong Zhao, MD
Role: primary
Other Identifiers
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MA-DM-IV-004
Identifier Type: -
Identifier Source: org_study_id
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