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NCT06448130

PHASE4

Henagliflozin's Impact on Prediabetes Remission

Sponsor: Shandong Provincial Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

984

Start Date

2024-06

Completion Date

2027-12

Last Updated

2024-06-07

Healthy Volunteers

Conditions

PreDiabetes Prediabetic State Type 2 Diabetes Glucose Metabolism Disorders

Interventions

DRUG

Henagliflozin 5mg

Henagliflozin 5mg + lifestyle intervention

DRUG

Henagliflozin 10mg

Henagliflozin 10mg+ lifestyle intervention

DRUG

Placebo

Placebo+ lifestyle intervention

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).

Locations (50)

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

Clinical Research Directory

Henagliflozin's Impact on Prediabetes Remission

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)