Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05663736
Status:
RECRUITING
Last Update Posted:
2023-03-08
First Post:
2022-12-15
Brief Title:
Effect of Gemigliptin Versus Glimepiride on Cardiac Diastolic Function in Patients With Type 2 Diabetes
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Comparison in Effect of Gemigliptin Versus Glimepiride on Cardiac Diastolic Function in Patients With Type 2 Diabetes Uncontrolled With Metformin
Status:
RECRUITING
Status Verified Date:
2023-03
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:
Among DPP-4 inhibitors gemigliptin is a relatively recently developed drug and many clinical studies have shown results that are equivalent to or superior to existing DPP-4 inhibitors such as sitagliptin However studies on the safety of gemigliptin in cardiovascular disease have not been conducted and studies on its effect on cardiac function are lacking Considering the increase in hospitalizations due to heart failure found in some DPP-4 inhibitor studies investigation of directly effect of gemigliptin on heart function would be clinically important
Detailed Description:
Many international guidelines including the American Diabetes Association and Korean diabetes association recommend metformin as an initial hypoglycemic agent They also suggest early active treatment for patients with type 2 diabetes T2D when it is difficult to reach the target blood sugar with metformin monotherapy alone This is a strategy to minimize the period of exposure to hyperglycemia However when choosing the second agent both efficacy and safety should be considered
The American Diabetes Association guidelines recommend to using glucagon-like peptide 1 receptor agonist GLP-1 RAs for patients with T2D at high atherosclerotic cardiovascular disease and sodium-glucose cotransporter-2 inhibitor for T2D patients at high risk of heart failure or chronic kidney disease However people at this condition are not majority in many countries
Sulfonylurea is an oral hypoglycemic agent that was first developed in the 1950s and has been widely used for a long time Since these sulfonylureas are complementary to metformin in their mechanism of action sulfonylureas and metformin are one of the suitable combination therapies In fact in a phase 3 clinical study conducted on Koreans compared to increasing the dose of metformin combined administration of glimepiride and metformin proved superior in the hypoglycemic effect However when glimepiride and metformin were combined hypoglycemia occurred more frequently than metformin monotherapy and there was a side effect of weight gain Therefore although sulfonylurea and metformin combination therapy is an effective combination in terms of lowering blood sugar there are doubts as to whether it is the optimal combination therapy due to side effects such as hypoglycemia and weight gain which are disadvantages of sulfonylurea itself
Dipeptidyl peptidase-4 DPP-4 inhibitors are an incretin-based therapy that have proven their hypoglycemic effect in both monotherapy and metformin combination therapy According to the incretin-based mechanism of action the risk of hypoglycemia is low and the weight is neutral with DPP-4 inhibitors In addition it can be used without serious adverse events On the contrary to most GLP-1 RAs DPP-4 inhibitors are oral antidiabetic agents which are convenient for physicians to prescribe as well as for patients to take Of note this class has been known to be more beneficial in Asian ethnic groups Thus DPP-4 inhibitors have been widely used in this region
Like sulfonylurea when used in combination with initial metformin it has a superior blood sugar lowering effect compared to metformin alone However when metformin is combined with a DPP-4 inhibitor the risk of hypoglycemia does not increase unlike when sulfonylurea is combined Therefore considering the safety related to the occurrence of hypoglycemia the DPP-4 inhibitor and metformin combination therapy may be the preferred choice over the sulfonylurea and metformin combination therapy In several phase 3 studies and registry studies in patients with T2D who failed metformin monotherapy the addition of a DPP-4 inhibitor to metformin was proven to be safe in hypoglycemia compared to the addition of a sulfonylurea
Among DPP-4 inhibitors gemigliptin is a relatively recently developed drug and many clinical studies have shown results that are equivalent to or superior to existing DPP-4 inhibitors such as sitagliptin However studies on the safety of gemigliptin in cardiovascular disease have not been conducted and studies on its effect on cardiac function are lacking Considering the increase in hospitalizations due to heart failure found in some DPP-4 inhibitor studies investigation of directly effect of gemigliptin on heart function would be clinically important
The American Diabetes Association guidelines recommend to using glucagon-like peptide 1 receptor agonist GLP-1 RAs for patients with T2D at high atherosclerotic cardiovascular disease and sodium-glucose cotransporter-2 inhibitor for T2D patients at high risk of heart failure or chronic kidney disease However people at this condition are not majority in many countries
Sulfonylurea is an oral hypoglycemic agent that was first developed in the 1950s and has been widely used for a long time Since these sulfonylureas are complementary to metformin in their mechanism of action sulfonylureas and metformin are one of the suitable combination therapies In fact in a phase 3 clinical study conducted on Koreans compared to increasing the dose of metformin combined administration of glimepiride and metformin proved superior in the hypoglycemic effect However when glimepiride and metformin were combined hypoglycemia occurred more frequently than metformin monotherapy and there was a side effect of weight gain Therefore although sulfonylurea and metformin combination therapy is an effective combination in terms of lowering blood sugar there are doubts as to whether it is the optimal combination therapy due to side effects such as hypoglycemia and weight gain which are disadvantages of sulfonylurea itself
Dipeptidyl peptidase-4 DPP-4 inhibitors are an incretin-based therapy that have proven their hypoglycemic effect in both monotherapy and metformin combination therapy According to the incretin-based mechanism of action the risk of hypoglycemia is low and the weight is neutral with DPP-4 inhibitors In addition it can be used without serious adverse events On the contrary to most GLP-1 RAs DPP-4 inhibitors are oral antidiabetic agents which are convenient for physicians to prescribe as well as for patients to take Of note this class has been known to be more beneficial in Asian ethnic groups Thus DPP-4 inhibitors have been widely used in this region
Like sulfonylurea when used in combination with initial metformin it has a superior blood sugar lowering effect compared to metformin alone However when metformin is combined with a DPP-4 inhibitor the risk of hypoglycemia does not increase unlike when sulfonylurea is combined Therefore considering the safety related to the occurrence of hypoglycemia the DPP-4 inhibitor and metformin combination therapy may be the preferred choice over the sulfonylurea and metformin combination therapy In several phase 3 studies and registry studies in patients with T2D who failed metformin monotherapy the addition of a DPP-4 inhibitor to metformin was proven to be safe in hypoglycemia compared to the addition of a sulfonylurea
Among DPP-4 inhibitors gemigliptin is a relatively recently developed drug and many clinical studies have shown results that are equivalent to or superior to existing DPP-4 inhibitors such as sitagliptin However studies on the safety of gemigliptin in cardiovascular disease have not been conducted and studies on its effect on cardiac function are lacking Considering the increase in hospitalizations due to heart failure found in some DPP-4 inhibitor studies investigation of directly effect of gemigliptin on heart function would be clinically important
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