Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767255
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2023-02-16
Brief Title:
Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue
Sponsor:
Hospital Universitario San Ignacio
Organization:
Hospital Universitario San Ignacio
Study Overview
Official Title:
Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue
Status:
RECRUITING
Status Verified Date:
2023-02
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:
The association of insulin degludec with liraglutide in the same device IDegLira is a potent but at the same time safe drug that reduces the risk of hypoglycemia when compared to a basal or basal-bolus insulin schedule
The DUAL Dual Action of Liraglutide and Insulin Degludec studies are the pivotal studies of this combination Specifically the DUAL VII study has demonstrated that ideglira is a non-inferior drug in terms of glycemic control versus a basal-bolus schedule in patients in the outpatient setting who have failed basal insulin
Although the basal-bolus insulin plus correction schedule is frequently used in hospitalized patients with hyperglycemia outpatient management with a complex insulin schedule creates challenges that are difficult to mitigate due to limited time for patient education during an acute illness and limited access to the physician responsible for post-discharge diabetes management
The use of IDegLira has not been evaluated in clinical studies in the hospital discharge setting where the authors believe it has great potential because it offers similar potency to the basal-bolus scheme but with greater safety with respect to hypoglycemia and less complexity for the patient because it is associated with fewer applications and less need for capillary self-monitoring
For this reason in the hospital-home transition scenario ideglira therapy in patients with poor metabolic control and requiring intensification therapy is proposed as an alternative to the basal-bolus scheme
The DUAL Dual Action of Liraglutide and Insulin Degludec studies are the pivotal studies of this combination Specifically the DUAL VII study has demonstrated that ideglira is a non-inferior drug in terms of glycemic control versus a basal-bolus schedule in patients in the outpatient setting who have failed basal insulin
Although the basal-bolus insulin plus correction schedule is frequently used in hospitalized patients with hyperglycemia outpatient management with a complex insulin schedule creates challenges that are difficult to mitigate due to limited time for patient education during an acute illness and limited access to the physician responsible for post-discharge diabetes management
The use of IDegLira has not been evaluated in clinical studies in the hospital discharge setting where the authors believe it has great potential because it offers similar potency to the basal-bolus scheme but with greater safety with respect to hypoglycemia and less complexity for the patient because it is associated with fewer applications and less need for capillary self-monitoring
For this reason in the hospital-home transition scenario ideglira therapy in patients with poor metabolic control and requiring intensification therapy is proposed as an alternative to the basal-bolus scheme
Detailed Description:
Type 2 diabetes mellitus DM 2 is a chronic non-communicable metabolic disease characterized by progressive deterioration of beta cell functionality which associated with the presence of insulin resistance results in persistent elevations of plasma glucose or hyperglycemia The objectives of its treatment are to prevent or delay complications and optimize quality of life
The American Diabetes Association ADA consensus report Standards of Medical Care in Diabetes-2021 recommends a patient-centered approach to choosing appropriate pharmacologic treatment of glycemia This includes consideration of key patient factors 1 important comorbidities such as atherosclerotic cardiovascular disease high-risk indicators of cardiovascular chronic kidney disease and heart failure 2 risk of hypoglycemia 3 effects on body weight 4 side effects 5 cost and 6 patient preferences
With these considerations in mind drug therapy should be initiated in conjunction with a lifestyle modification consultation focused on diet and physical activity Considering the progressive nature of the disease monotherapy only achieves glycemic control for a few years and treatment intensification is required as the disease progresses however therapeutic inertia leads to delayed intensification in diabetic patients who are not at glycemic control goals mainly when it comes to the use of injectable therapies such as insulins
In recent years two combinations of basal insulin with GLP-1 analog received regulatory approval from the European Medicines Agency and the US Food and Drug Administration Agency These therapeutic strategies are fixed ratio combinations of insulin degludec U100 and liraglutide IDegLira and insulin glargine U100 and lixisenatide IGlarLixi Both options demonstrated non-inferiority or superiority in reducing Hb1Ac levels in terms of glycemic control compared to their individual components in monotherapy in the DUAL I study for IDegLira and in the LixiLan-O study for IGlarLixi
Clinical trials supporting the efficacy and safety of IDegLira in the outpatient setting include DUAL Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes On the other hand there are authors who propose considering the use of IDegLira as the first injectable therapy in type 2 diabetic patients and as a therapeutic alternative in those who do not reach glycemic control goals with pharmacological treatment including monotherapy with GLP1 analogues basal insulin or therapy with multiple doses of insulin in patients with recurrent hypoglycemia
Considering the above injectable therapy combined with IDegLira is proposed as an alternative for therapeutic intensification in patients with uncontrolled DM 2 since it has demonstrated efficacy and safety in the management of this pathology achieving adequate glycemic control while leading to weight loss lower rates of hypoglycemia and savings in insulin doses in addition to providing a simple application scheme compared to the basal-bolus scheme
In patients with DM 2 hospitalization represents an important change in medication most consensus and guidelines propose the use of insulin therapy for glycemic control during hospital stay
However therapy at the time of hospital discharge should be adjusted and reconciled with the use of other non-insulin diabetes medications
The American Diabetes Association ADA consensus report Standards of Medical Care in Diabetes-2021 recommends a patient-centered approach to choosing appropriate pharmacologic treatment of glycemia This includes consideration of key patient factors 1 important comorbidities such as atherosclerotic cardiovascular disease high-risk indicators of cardiovascular chronic kidney disease and heart failure 2 risk of hypoglycemia 3 effects on body weight 4 side effects 5 cost and 6 patient preferences
With these considerations in mind drug therapy should be initiated in conjunction with a lifestyle modification consultation focused on diet and physical activity Considering the progressive nature of the disease monotherapy only achieves glycemic control for a few years and treatment intensification is required as the disease progresses however therapeutic inertia leads to delayed intensification in diabetic patients who are not at glycemic control goals mainly when it comes to the use of injectable therapies such as insulins
In recent years two combinations of basal insulin with GLP-1 analog received regulatory approval from the European Medicines Agency and the US Food and Drug Administration Agency These therapeutic strategies are fixed ratio combinations of insulin degludec U100 and liraglutide IDegLira and insulin glargine U100 and lixisenatide IGlarLixi Both options demonstrated non-inferiority or superiority in reducing Hb1Ac levels in terms of glycemic control compared to their individual components in monotherapy in the DUAL I study for IDegLira and in the LixiLan-O study for IGlarLixi
Clinical trials supporting the efficacy and safety of IDegLira in the outpatient setting include DUAL Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes On the other hand there are authors who propose considering the use of IDegLira as the first injectable therapy in type 2 diabetic patients and as a therapeutic alternative in those who do not reach glycemic control goals with pharmacological treatment including monotherapy with GLP1 analogues basal insulin or therapy with multiple doses of insulin in patients with recurrent hypoglycemia
Considering the above injectable therapy combined with IDegLira is proposed as an alternative for therapeutic intensification in patients with uncontrolled DM 2 since it has demonstrated efficacy and safety in the management of this pathology achieving adequate glycemic control while leading to weight loss lower rates of hypoglycemia and savings in insulin doses in addition to providing a simple application scheme compared to the basal-bolus scheme
In patients with DM 2 hospitalization represents an important change in medication most consensus and guidelines propose the use of insulin therapy for glycemic control during hospital stay
However therapy at the time of hospital discharge should be adjusted and reconciled with the use of other non-insulin diabetes medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None