Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613854
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-SEMPA
Brief Summary:
The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes It will also learn about the effect of the combination treatment on body weight body composition blood lipids oxidative stress inflammation metabolic control insulin resistance and insulin secretion from pancreas together with its safety profile The main questions it aims to answer are
Does early combination with two antidiabetic drugs improve blood glucose levels determined by continuous glucose monitoring system
Is early combination treatment as safe as treatment with a single antidiabetic drug
Does early combination treatment reduces the need for rescue therapy
Does early combination treatment reduces body weight and improves body composition
Does early combination treatment improves blood lipid parameters oxidative stress and inflammation
Does early combination treatment improves metabolic parameters
Does early combination treatment improves insulin resistance and insulin secretion
Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes
Participants will
Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks
Visit the clinic four times during the study duration for checkups and tests
Carry a continuous glucose monitoring sensor for 14 days prior to study visits
Does early combination with two antidiabetic drugs improve blood glucose levels determined by continuous glucose monitoring system
Is early combination treatment as safe as treatment with a single antidiabetic drug
Does early combination treatment reduces the need for rescue therapy
Does early combination treatment reduces body weight and improves body composition
Does early combination treatment improves blood lipid parameters oxidative stress and inflammation
Does early combination treatment improves metabolic parameters
Does early combination treatment improves insulin resistance and insulin secretion
Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes
Participants will
Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks
Visit the clinic four times during the study duration for checkups and tests
Carry a continuous glucose monitoring sensor for 14 days prior to study visits
Detailed Description:
Type 2 diabetes T2D is a progressive chronic disease and represents a significant risk factor for morbidity and mortality due to cardiovascular disease In addition to managing glycemia the use of antihyperglycemic medications with further and independent cardiovascular benefits is recommended in managing individuals with T2D These medications primarily include sodium-glucose cotransporter 2 inhibitors SGLT2i and glucagon-like peptide-1 receptor agonists GLP-1RA Traditionally treatment of T2D followed a stepwise intensification by adding antihyperglycemic drugs if optimal glycemic control was not achieved However current American Diabetes Association guidelines recommend considering early combination therapy at treatment initiation particularly at high baseline glycated hemoglobin HbA1c levels to shorten the time to achieve glycemic goals
In everyday clinical practice however treatment intensification is often delayed due to clinical inertia even when glycemic control is suboptimal Early intensive treatment of T2D has been shown to improve glycemic control reduce mortality and lower the risk of both microvascular and macrovascular complications while also improving the durability of the glycemic effect
Previous randomized clinical trials on early combination therapy for T2D have primarily focused on glycemic control as determined by traditional glycemic parameters such as fasting glucose and HbA1c However new insights suggest that these measures alone are insufficient for a holistic assessment of glycemic control in diabetes There is now a recognized need to consider additional indicators of glycemic control obtained through continuous glucose monitoring CGM systems Furthermore data are lacking on the direct comparison of the early combination treatment with either SGLT2i or GLP-1RA on top of metformin
In this 26-week prospective open-label interventional randomized single-center clinical trial with a 3-week run-in period we aim to investigate the effect of early combination treatment with metformin and GLP-1RA or SGLT2i compared to standard monotherapy with metformin and subsequent escalation of antihyperglycemic treatment on glycemic control as assessed by continuous glucose monitoring systems and HbA1c body weight body composition lipid profile oxidative stress inflammation metabolic control insulin resistance and pancreatic beta-cell function in adults with short duration T2D The primary outcome of the study will be glycemic control assessed by time in range TIR
The study will include individuals of both sexes of any race or ethnicity aged between 18 and 70 with a duration of T2D of less than 2 years HbA1c levels 80 on monotherapy with metformin and naive to treatment with GLP-1RA and SGLT2i
After the initial 3-week run-in period patients will be randomized based on sex age and TIR during the run-in period into three intervention groups in a 111 ratio
i a control group continuing metformin monotherapy ii the first study group receiving metformin and oral semaglutide and iii the second study group receiving metformin and empagliflozin
Patients will then be monitored approximately every 13 weeks 3 months up to 26 weeks 6 months Prior to randomization participants will receive a study package containing 3 sensors and 1 reader of the CGM system The first sensor will be placed on the participants at the start of the run-in period and subsequent sensors will be self-applied by participants at least 14 days before the last two study visits at week 13 and week 26
At each study visit a review of medical records a clinical examination and blood collection for laboratory tests will be conducted At randomization week 0 and during the final study visit week 26 all participants will undergo a modified oral glucose tolerance test mOGTT to assess insulin resistance and pancreatic beta-cell function Additionally the first 20 participants from each intervention group will undergo whole-body imaging to evaluate body composition In the case of inadequately controlled glycemia rescue treatment with gliclazide from the sulfonylurea class will be initiated
In everyday clinical practice however treatment intensification is often delayed due to clinical inertia even when glycemic control is suboptimal Early intensive treatment of T2D has been shown to improve glycemic control reduce mortality and lower the risk of both microvascular and macrovascular complications while also improving the durability of the glycemic effect
Previous randomized clinical trials on early combination therapy for T2D have primarily focused on glycemic control as determined by traditional glycemic parameters such as fasting glucose and HbA1c However new insights suggest that these measures alone are insufficient for a holistic assessment of glycemic control in diabetes There is now a recognized need to consider additional indicators of glycemic control obtained through continuous glucose monitoring CGM systems Furthermore data are lacking on the direct comparison of the early combination treatment with either SGLT2i or GLP-1RA on top of metformin
In this 26-week prospective open-label interventional randomized single-center clinical trial with a 3-week run-in period we aim to investigate the effect of early combination treatment with metformin and GLP-1RA or SGLT2i compared to standard monotherapy with metformin and subsequent escalation of antihyperglycemic treatment on glycemic control as assessed by continuous glucose monitoring systems and HbA1c body weight body composition lipid profile oxidative stress inflammation metabolic control insulin resistance and pancreatic beta-cell function in adults with short duration T2D The primary outcome of the study will be glycemic control assessed by time in range TIR
The study will include individuals of both sexes of any race or ethnicity aged between 18 and 70 with a duration of T2D of less than 2 years HbA1c levels 80 on monotherapy with metformin and naive to treatment with GLP-1RA and SGLT2i
After the initial 3-week run-in period patients will be randomized based on sex age and TIR during the run-in period into three intervention groups in a 111 ratio
i a control group continuing metformin monotherapy ii the first study group receiving metformin and oral semaglutide and iii the second study group receiving metformin and empagliflozin
Patients will then be monitored approximately every 13 weeks 3 months up to 26 weeks 6 months Prior to randomization participants will receive a study package containing 3 sensors and 1 reader of the CGM system The first sensor will be placed on the participants at the start of the run-in period and subsequent sensors will be self-applied by participants at least 14 days before the last two study visits at week 13 and week 26
At each study visit a review of medical records a clinical examination and blood collection for laboratory tests will be conducted At randomization week 0 and during the final study visit week 26 all participants will undergo a modified oral glucose tolerance test mOGTT to assess insulin resistance and pancreatic beta-cell function Additionally the first 20 participants from each intervention group will undergo whole-body imaging to evaluate body composition In the case of inadequately controlled glycemia rescue treatment with gliclazide from the sulfonylurea class will be initiated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None