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Clinical Trial Details

Trial ID: L2372
Source ID: NCT06448130
Associated Drug: Henagliflozin 5mg
Title: Henagliflozin's Impact on Prediabetes Remission
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: PreDiabetes|Prediabetic State|Type 2 Diabetes|Glucose Metabolism Disorders
Interventions: DRUG: Henagliflozin 5mg|DRUG: Henagliflozin 10mg|DRUG: Placebo
Outcome Measures: 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|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|Changes in HbA1c Levels, Changes in HbA1c levels over the 24-month period in the three study groups., From 0 to 24 months|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|Major Adverse Cardiovascular Events, Major Adverse Cardiovascular Events (MACE) in the three study groups over 0-24 months., From 0 to 24 months|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|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
Sponsor/Collaborators: Sponsor: Shandong Provincial Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 984
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-12
Results First Posted:
Last Update Posted: 2024-06-07
Locations: 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, Ha'erbin, 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
URL: https://clinicaltrials.gov/show/NCT06448130