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Clinical Trials in China / NCT06448130
Starting soon Phase 4

Henagliflozin's Impact on Prediabetes Remission

NCT06448130 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Provincial Hospital
Phase
Phase 4
Started
2024-06
Last updated
2024-06-07

Condition(s) studied

PreDiabetesPrediabetic StateType 2 DiabetesGlucose Metabolism Disorders

Investigational drug(s) / intervention(s)

Henagliflozin 5mgHenagliflozin 10mgPlacebo

Henagliflozin 5mg: Henagliflozin 5mg + lifestyle intervention

Henagliflozin 10mg: Henagliflozin 10mg+ lifestyle intervention

Placebo: Placebo+ lifestyle intervention

Study 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. 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female subjects between the ages of 18 and 65 years; 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: 1. Allergic to Henagliflozin; 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).

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Chuzhou First People's Hospital Chuzhou Anhui
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui
Fujian Medical University Union Hospital Fuzhou Fujian
Fujian Provincial Hospital Fuzhou Fujian
LanZhou University Lanzhou Gansu
Shunde Hospital of Southern Medical University Foshan Guangdong
Southern Medical University Guangzhou Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guanzhou Guangdong
Shenzhen Second People's Hospital Shenzhen Guangdong
First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
North China University of Technology Affiliated Hospital Tangshan Hebei
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
Xinyang Central Hospital Xinyang Henan
First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Tongji Hospital Wuhan Hubei
Xiangyang Central Hospital Xiangyang Hubei
Xiangya Hospital of Central South University Changsha Hunan
The Second Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia
Second Affiliated Hospital of Nanchang University Nanchang Jiangsu
The First Affiliated Hospital with Nanjing Medical University, Nanjing Jiangsu
Wuxi People's Hospital Wuxi Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
First Affiliated Hospital of China Medical University Shenyang Liaoning
People's Hospital of Liaoning Province Shenyang Liaoning
Ningxia Medical University Yinchuan Ningxia
Binzhou City Central Hospital Binzhou Shandong
Dongying People's Hospital Dongying Shandong
Jinan Central Hospital Jinan Shandong
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong
Liaocheng People's Hospital Liaocheng Shandong
The Second Affiliated Hospital of Shandong First Medical University Tai’an Shandong
The Affiliated Hospital of Weifang Medical University Weifang Shandong
Weifang People's Hospital Weifang Shandong
Yantai Affiliated Hospital of Binzhou Medical University Yantai Shandong
Affiliated Hospital of Southwest Medical University Luzhou Sichuan
First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
The Central Hospital of Lishui City Lishui Zhejiang
First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang

+ 10 more sites — see the full list on the official registry below.

More Shandong Provincial Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06448130 on ClinicalTrials.gov ↗ ← All trials in China