Type 2 Diabetes Clinical Trial
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. 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.
Status | Not yet recruiting |
Enrollment | 984 |
Est. completion date | December 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia |
China | Beijing Chao Yang Hospital | Beijing | |
China | Beijing Hospital | Beijing | |
China | Beijing Luhe Hospital | Beijing | |
China | Binzhou City Central Hospital | Binzhou | Shandong |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | Xiangya Hospital of Central South University | Changsha | Hunan |
China | First Affiliated Hospital of Chongqing Medical University | Chongqing | |
China | Chuzhou First People's Hospital | Chuzhou | Anhui |
China | Dongying People's Hospital | Dongying | Shandong |
China | Shunde Hospital of Southern Medical University | Foshan | Guangdong |
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
China | Fujian Provincial Hospital | Fuzhou | Fujian |
China | Southern Medical University | Guangzhou | Guangdong |
China | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guanzhou | Guangdong |
China | The Second Affiliated Hospital of Harbin Medical University | Ha'erbin | Heilongjiang |
China | The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui |
China | Jinan Central Hospital | Jinan | Shandong |
China | Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | LanZhou University | Lanzhou | Gansu |
China | Liaocheng People's Hospital | Liaocheng | Shandong |
China | The Central Hospital of Lishui City | Lishui | Zhejiang |
China | Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan |
China | Second Affiliated Hospital of Nanchang University | Nanchang | Jiangsu |
China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
China | The First Affiliated Hospital with Nanjing Medical University, | Nanjing | Jiangsu |
China | First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
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 | First Affiliated Hospital of China Medical University | Shenyang | Liaoning |
China | People's Hospital of Liaoning Province | Shenyang | Liaoning |
China | Shenzhen Second People's Hospital | Shenzhen | Guangdong |
China | The Second Affiliated Hospital of Shandong First Medical University | Tai'an | Shandong |
China | North China University of Technology Affiliated Hospital | Tangshan | Hebei |
China | Peking University Binhai Hospital | Tianjin | |
China | Tianjin First Central Hospital | Tianjin | |
China | First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
China | The Affiliated Hospital of Weifang Medical University | Weifang | Shandong |
China | Weifang People's Hospital | Weifang | Shandong |
China | First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
China | Wenzhou Central Hospital | Wenzhou | Zhejiang |
China | Tongji Hospital | Wuhan | Hubei |
China | Wuxi People's Hospital | Wuxi | Jiangsu |
China | Xiangyang Central Hospital | Xiangyang | Hubei |
China | Xinyang Central Hospital | Xinyang | Henan |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
China | Yantai Affiliated Hospital of Binzhou Medical University | Yantai | Shandong |
China | Ningxia Medical University | Yinchuan | Ningxia |
China | First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Shandong Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Blood Glucose Control Normalization | Proportion and duration of normalization of blood glucose levels within 24 months in the three study groups. | From 6 months post-intervention to 24 months | |
Secondary | Incidence of New-Onset Type 2 Diabetes | Incidence of new-onset type 2 diabetes within 24 months in the three study groups. | From 0 to 24 months | |
Secondary | Changes in HbA1c Levels | Changes in HbA1c levels over the 24-month period in the three study groups. | From 0 to 24 months | |
Secondary | 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. | From 12 months to 24 months | |
Secondary | Changes in blood pressure over 24 Months | Changes in systolic and diastolic blood pressure in the three study groups over 24 Months. | From 0 to 24 months | |
Secondary | Changes in serum uric acid levels over 24 Months | Changes in serum uric acid levels in the three study groups over 24 Months. | From 0 to 24 months | |
Secondary | Changes in hepatic steatosis over 24 Months | Changes in hepatic steatosis assessed by abdominal ultrasound in the three study groups over 24 Months. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | Changes in Body Weight over 24 Months | Measurement of body weight in kilograms (kg) at multiple time points within the 24-month period. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | 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. | From 0 to 24 months | |
Secondary | Changes in Waist Circumference over 24 Months | Measurement of waist circumference in centimeters (cm) at multiple time points within the 24-month period. | From 0 to 24 months | |
Secondary | Changes in Hip Circumference over 24 Months | Measurement of hip circumference in centimeters (cm) at multiple time points within the 24-month period. | From 0 to 24 months | |
Secondary | 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. | From 0 to 6 months | |
Secondary | 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. | From 0 to 6 months | |
Secondary | Major Adverse Cardiovascular Events | Major Adverse Cardiovascular Events (MACE) in the three study groups over 0-24 months. | From 0 to 24 months | |
Secondary | Risk of Retinal Diseases | Risk of retinal diseases (e.g., diabetic retinopathy) in the three study groups over 0-24 months. | From 0 to 24 months | |
Secondary | Risk of Renal diseases | Risk of renal diseases (e.g., diabetic nephropathy/chronic kidney disease) in the three study groups over 0-24 months. | From 0 to 24 months |
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