Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448130
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-15
Brief Title:
Henagliflozins Impact on Prediabetes Remission
Sponsor:
Shandong Provincial Hospital
Organization:
Shandong Provincial Hospital
Study Overview
Official Title:
Effect of Henagliflozin on the Remission of Prediabetes Population A National Multicenter Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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
The studys 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
Detailed Description:
This research is launched in light of the global surge in prediabetes a condition that markedly increases the risk of developing type 2 diabetes and related vascular complications While lifestyle modifications are the frontline defense against prediabetes the variability in individual responses often requires the integration of pharmacological treatments Studies have shown that drugs such as metformin acarbose SGLT2 inhibitors GLP-1 agonists GIPGLP-1 receptor agonists thiazolidinediones and orlistat effectively curb the progression to diabetes Yet there remains a gap in specific research addressing the intervention needs of the prediabetic population in China
Currently acarbose is the only drug approved in the Chinese market for treating patients with impaired glucose tolerance highlighting a limited range of therapeutic options for prediabetes SGLT2 inhibitors as a newer class of hypoglycemic agents have demonstrated significant promise in reducing major cardiovascular events in high-risk patients with type 2 diabetes enhancing outcomes in heart failure and providing renal protection However there is a scarcity of large-scale prospective studies on the impact of SGLT2 inhibitors in prediabetes Henagliflozin the first original SGLT2 inhibitor developed in China and launched on December 31 2021 is being studied to assess its effectiveness combined with lifestyle interventions in the prediabetic demographic aiming to fill a crucial void in the current treatment paradigm
This study aims to assess the combined benefits of Henagliflozin and lifestyle modifications in managing prediabetes The investigators conducted a two-year prospective randomized double-blind placebo-controlled trial across 50 medical institutions in various provinces of China It is planned to enroll 984 adult prediabetic patients who had not previously been treated with antidiabetic medications Participants meeting inclusion criteria were randomly assigned to one of three groups Henagliflozin 5mg Henagliflozin 10mg or placebo The intensive intervention phase consisting of pharmacotherapy combined with lifestyle changes lasted for 6 months followed by an 18-month follow-up period focusing solely on lifestyle interventions
The primary endpoint is the proportion of participants achieving normoglycemia after 6 months of intervention with subsequent assessments at 12 months Secondary endpoints include short-term 0-12 months and long-term 12-24 months changes in glucose control metabolic indicators such as body weight body mass index BMI body fat content waist and hip circumference lipid profiles blood pressure serum uric acid levels hepatic steatosis and carotid intima-media thickness Exploratory outcomes encompass changes in C-peptide and insulin levels from baseline to 6 months and the risk of major adverse cardiovascular events MACE from baseline to 24 months and beyond
Currently acarbose is the only drug approved in the Chinese market for treating patients with impaired glucose tolerance highlighting a limited range of therapeutic options for prediabetes SGLT2 inhibitors as a newer class of hypoglycemic agents have demonstrated significant promise in reducing major cardiovascular events in high-risk patients with type 2 diabetes enhancing outcomes in heart failure and providing renal protection However there is a scarcity of large-scale prospective studies on the impact of SGLT2 inhibitors in prediabetes Henagliflozin the first original SGLT2 inhibitor developed in China and launched on December 31 2021 is being studied to assess its effectiveness combined with lifestyle interventions in the prediabetic demographic aiming to fill a crucial void in the current treatment paradigm
This study aims to assess the combined benefits of Henagliflozin and lifestyle modifications in managing prediabetes The investigators conducted a two-year prospective randomized double-blind placebo-controlled trial across 50 medical institutions in various provinces of China It is planned to enroll 984 adult prediabetic patients who had not previously been treated with antidiabetic medications Participants meeting inclusion criteria were randomly assigned to one of three groups Henagliflozin 5mg Henagliflozin 10mg or placebo The intensive intervention phase consisting of pharmacotherapy combined with lifestyle changes lasted for 6 months followed by an 18-month follow-up period focusing solely on lifestyle interventions
The primary endpoint is the proportion of participants achieving normoglycemia after 6 months of intervention with subsequent assessments at 12 months Secondary endpoints include short-term 0-12 months and long-term 12-24 months changes in glucose control metabolic indicators such as body weight body mass index BMI body fat content waist and hip circumference lipid profiles blood pressure serum uric acid levels hepatic steatosis and carotid intima-media thickness Exploratory outcomes encompass changes in C-peptide and insulin levels from baseline to 6 months and the risk of major adverse cardiovascular events MACE from baseline to 24 months and beyond
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None