Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187285
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-16
Brief Title:
Efficay and Safety of Empagliflozin Versus Sitagliptin for the In-patient Management of Hyperglycemia
Sponsor:
Medanta The Medicity India
Organization:
Medanta The Medicity India
Study Overview
Official Title:
Efficay and Safety of Empagliflozin Versus Sitagliptin for the In-patient Management of Hyperglycemia Randomised Control
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Clinical guidelines from professional organizations have recommended the use of multidose insulin regimens as the preferred therapy for glycaemic control in patients admitted to hospital in a non-intensive-careunit setting The use of a basal-bolus regimen with a once daily basal insulin and rapid-acting insulin analogs before meals has been shown to improve glycaemic control and to reduce the rate of hospital complications in general medical and surgical patients with type 2 diabetesThe basal-bolus regimen however is labour intensive requiring several insulin injections and is associated with a high risk of hypoglycaemia Hypoglycaemia has been reported in 12 to 32 of patients in general medicine and surgery with type 2 diabetes treated with basal-bolus insulin regimensBecause of these limitations alternative treatment regimens are needed that could improve glycaemic control and clinical outcomes while facilitating care and minimising the risk of hypoglycaemia in patients with diabetes
Detailed Description:
The management of hyperglycemia in noncritically ill hospitalized patients with diabetes mellitus is mainly based on insulin therapy This usually consists of one dose of long-acting basal insulin and three doses of rapid-acting premeal bolus insulins basal-bolus insulin Basal-bolus insulin therapy is however labor intensive requiring multiple insulin injections per day and multiple daily blood glucose checks The use of oral antidiabetic medications has generally not been recommended for patients admitted to the hospital This is because of the lack of safety and efficacy data and concerns about hypoglycemia Oral medication usually has a slow onset of action that might preclude daily dose adjustments and have considerable interactions with concomitantly administered drugs Oral antidiabetic medications are also withheld during hospitalization because of several safety concerns related to altered pharmacokinetics in cases of end-stage organ disease such as renal or liver failure Dipeptidyl peptidase-4 inhibitors sitagliptin and linagliptin have been studied for the treatment of hospitalized patients in the noncritical care setting Complementary to insulin therapy these drugs improved glycemia and were found to be safe Sodium-glucose cotransporter type 2 SGLT2 inhibitors are another class of oral glucose-lowering medication that is increasingly being used in patients with T2D due to multiple pleiotropic efects These drugs reduce cardiovascular mortality especially by reducing the risk of heart failure and also improve renal outcomes Recently two randomized controlled trials demonstrated improvement in several cardiac outcomes when SGLT2 inhibitors empaglifozin and dapaglifozin were initiated in patients admitted for acute heart failure with or without diabetes This trial aimed to examine the efficacy and safety of Empagliflozin in Hopitalised patients in comparison to Sitagliptin
Hyperglycaemia is a common and serious health-care problem in hospitals reported in approximately 30 of patients in general medicine and surgery with and without a history of previous diabetes mellitusExtensive evidence from observational and randomised clinical studies in patients admitted to hospital indicates that hyperglycaemia in patients both with and without diabetes is a predictor of poor outcomeIn such patients hyperglycaemia is associated with prolonged hospital stay increased incidence of infections hospital complications and death Improvement in glycaemic control with insulin therapy has been shown to reduce the risk of infection and complications in patients in hospital critical-care units and in patients admitted to general surgical and medical services Although insulin therapy is the standard of care in hospitals it is a source of medication errors and increased risk of hypoglycemia An analysis of medication errors between 2006 and 2008 revealed that insulin was the drug with the greatest number of medication errors in hospitals Hypoglycemia in the hospital has been associated with adverse cardiovascular outcomes such as prolonged QT intervals ischemic electrocardiogram changesangina arrhythmias sudden death and increased inflammationIn addition insulin-induced hypoglycemia is associated with increases in C-reactive protein and proinflammatory cytokines TNF-α interleukin-1β IL-6 and interleukin-8 markers of lipid peroxidation ROS and leukocytosis The use of oral antidiabetic agents is not recommended in hospitals because few data are available regarding their safety and efficacy in the inpatient setting Major limitations to the use of oral agents in the hospital include their side effect profiles and slow onset of action which does not allow for rapid attainment of glycemic control or dose adjustments to meet the changing needs of acutely ill patients Sodium glucose co-transporter 2 SGLT-2 inhibitors are a new class of oral antidiabetic medications that increase urinary glucose excretion by reducing renal glucose reabsorption in the proximal convoluted tubules Canaglifozin and dapaglifozin are the two available drugs approved by the US Food and Drug Administration for management of type 2 diabetes Both agents are effective in reducing A1C by 06-08 with a low risk of hypoglycemia A recently published randomized pilot study assessed the safety and efficacy of SGLT2 inhibitor Dapagliflozin for the inpatient management of type 2 diabetes37 In this study done in hospitalized patients with T2D admitted for cardiac surgery treatment with dapaglifozin 10 mg once a day plus basal-bolus insulin or basal-bolus insulin regimen alone in the early postoperative period resulted in similar glycemic control There was a rapid improvement in glycemic control in both groups without signifcant diferences in mean daily blood glucose number and percentage of blood glucose values within the target of 70-180 mgdL total daily insulin doses and number of daily insulin injections As the use of dapaglifozin complementary to basal-bolus insulin did not reduce insulin dose or the number of insulin injections per day therefore dapaglifozin lacks glycemic efficacy in hospitalized cardiac surgery patients A recently published randomized pilot study assessed the safety and efficacy of the DPP-4 inhibitor sitagliptin for the inpatient management of type 2 diabetes31In this trial patients treated with diet oral antidiabetic agents or a low daily insulin dose 04 unitskgday were randomized to sitagliptin alone or in combination with low-dose insulin glargine or to a basal-bolus insulin regimen plus supplemental doses of insulin lispro Glycemic control improved similarly in all treatment groups The trial met the non-inferiority threshold for the primary endpoint of differences between the sitagliptin-basal and basal-bolus groups for mean daily blood glucose concentrations Of patients with type 2 diabetes admitted to general medicine and surgery services in hospital treatment with a daily dose of sitagliptin and basal insulin or with a basal bolus regimen resulted in similar glycaemic control and frequency of complications
Hyperglycaemia is a common and serious health-care problem in hospitals reported in approximately 30 of patients in general medicine and surgery with and without a history of previous diabetes mellitusExtensive evidence from observational and randomised clinical studies in patients admitted to hospital indicates that hyperglycaemia in patients both with and without diabetes is a predictor of poor outcomeIn such patients hyperglycaemia is associated with prolonged hospital stay increased incidence of infections hospital complications and death Improvement in glycaemic control with insulin therapy has been shown to reduce the risk of infection and complications in patients in hospital critical-care units and in patients admitted to general surgical and medical services Although insulin therapy is the standard of care in hospitals it is a source of medication errors and increased risk of hypoglycemia An analysis of medication errors between 2006 and 2008 revealed that insulin was the drug with the greatest number of medication errors in hospitals Hypoglycemia in the hospital has been associated with adverse cardiovascular outcomes such as prolonged QT intervals ischemic electrocardiogram changesangina arrhythmias sudden death and increased inflammationIn addition insulin-induced hypoglycemia is associated with increases in C-reactive protein and proinflammatory cytokines TNF-α interleukin-1β IL-6 and interleukin-8 markers of lipid peroxidation ROS and leukocytosis The use of oral antidiabetic agents is not recommended in hospitals because few data are available regarding their safety and efficacy in the inpatient setting Major limitations to the use of oral agents in the hospital include their side effect profiles and slow onset of action which does not allow for rapid attainment of glycemic control or dose adjustments to meet the changing needs of acutely ill patients Sodium glucose co-transporter 2 SGLT-2 inhibitors are a new class of oral antidiabetic medications that increase urinary glucose excretion by reducing renal glucose reabsorption in the proximal convoluted tubules Canaglifozin and dapaglifozin are the two available drugs approved by the US Food and Drug Administration for management of type 2 diabetes Both agents are effective in reducing A1C by 06-08 with a low risk of hypoglycemia A recently published randomized pilot study assessed the safety and efficacy of SGLT2 inhibitor Dapagliflozin for the inpatient management of type 2 diabetes37 In this study done in hospitalized patients with T2D admitted for cardiac surgery treatment with dapaglifozin 10 mg once a day plus basal-bolus insulin or basal-bolus insulin regimen alone in the early postoperative period resulted in similar glycemic control There was a rapid improvement in glycemic control in both groups without signifcant diferences in mean daily blood glucose number and percentage of blood glucose values within the target of 70-180 mgdL total daily insulin doses and number of daily insulin injections As the use of dapaglifozin complementary to basal-bolus insulin did not reduce insulin dose or the number of insulin injections per day therefore dapaglifozin lacks glycemic efficacy in hospitalized cardiac surgery patients A recently published randomized pilot study assessed the safety and efficacy of the DPP-4 inhibitor sitagliptin for the inpatient management of type 2 diabetes31In this trial patients treated with diet oral antidiabetic agents or a low daily insulin dose 04 unitskgday were randomized to sitagliptin alone or in combination with low-dose insulin glargine or to a basal-bolus insulin regimen plus supplemental doses of insulin lispro Glycemic control improved similarly in all treatment groups The trial met the non-inferiority threshold for the primary endpoint of differences between the sitagliptin-basal and basal-bolus groups for mean daily blood glucose concentrations Of patients with type 2 diabetes admitted to general medicine and surgery services in hospital treatment with a daily dose of sitagliptin and basal insulin or with a basal bolus regimen resulted in similar glycaemic control and frequency of complications
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?:
False
Is an FDA AA801 Violation?:
None