Henagliflozin's Impact on Prediabetes Remission
Effect of Henagliflozin on the Remission of Prediabetes Population: A National Multicenter, Randomized Controlled Study
1 other identifier
interventional
984
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2024
Longer than P75 for phase_4
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 7, 2024
June 1, 2024
2.5 years
May 15, 2024
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
From 6 months post-intervention to 12 months
Secondary Outcomes (22)
Blood Glucose Control Normalization
From 6 months post-intervention to 24 months
Incidence of New-Onset Type 2 Diabetes
From 0 to 24 months
Changes in HbA1c Levels
From 0 to 24 months
Impact of Glycemic Status at 12 Months
From 12 months to 24 months
Changes in blood pressure over 24 Months
From 0 to 24 months
- +17 more secondary outcomes
Study Arms (3)
Henagliflozin5mg + lifestyle intervention
EXPERIMENTALHenagliflozin 5mg+ placebo 10mg po qd + lifestyle intervention for 6 months
Henagliflozin10mg+ lifestyle intervention
EXPERIMENTALHenagliflozin 10mg+ placebo 5mg po qd + lifestyle intervention for 6 months
placebo+ lifestyle intervention
PLACEBO COMPARATORplacebo 10mg + placebo 5mg po qd + lifestyle intervention for 6 months
Interventions
Henagliflozin 5mg + lifestyle intervention
Henagliflozin 10mg+ lifestyle intervention
Placebo+ lifestyle intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Chuzhou First People's Hospital
Chuzhou, Anhui, 239000, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350000, China
LanZhou University
Lanzhou, Gansu, 730000, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, 528000, China
Southern Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, 510000, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000, China
North China University of Technology Affiliated Hospital
Tangshan, Hebei, 063000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Xinyang Central Hospital
Xinyang, Henan, 464000, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital
Wuhan, Hubei, 430000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441100, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014000, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangsu, 330299, China
The First Affiliated Hospital with Nanjing Medical University,
Nanjing, Jiangsu, 210000, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
People's Hospital of Liaoning Province
Shenyang, Liaoning, 110000, China
Ningxia Medical University
Yinchuan, Ningxia, 750000, China
Binzhou City Central Hospital
Binzhou, Shandong, 256600, China
Dongying People's Hospital
Dongying, Shandong, 257000, China
Jinan Central Hospital
Jinan, Shandong, 250000, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000, China
The Affiliated Hospital of Weifang Medical University
Weifang, Shandong, 261000, China
Weifang People's Hospital
Weifang, Shandong, 261000, China
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong, 264000, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The Central Hospital of Lishui City
Lishui, Zhejiang, 323000, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000, China
Beijing Hospital
Beijing, 100000, China
Beijing Luhe Hospital
Beijing, 100000, China
Beijing Chao Yang Hospital
Beijing, 100005, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, 400000, China
Baoshan Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, 200000, China
Shanghai 10th People's Hospital
Shanghai, 200000, China
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, 200000, China
Peking University Binhai Hospital
Tianjin, 300000, China
Tianjin First Central Hospital
Tianjin, 300000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 15, 2024
First Posted
June 7, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
June 7, 2024
Record last verified: 2024-06