Last updated 21 months ago

Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue

66 patients around the world
Available in Colombia
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 U.S. 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.
Hospital Universitario San Ignacio
1Research sites
66Patients around the world

This study is for people with

Diabetes
Diabetes mellitus type 2

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Patients over 18 years of age with a diagnosis of type 2 diabetes mellitus who have received basal-bolus insulin during hospitalization and who, at the time of hospital discharge, are considered necessary to continue this scheme (basal-bolus).
Patient with diagnosis or suspicion of DM1.
Inability of the patient or family member to continue injectable therapy at home.
CKD with GFR < 15 ml/minute by CKD EPI.
History of chronic or acute pancreatitis in the last 3 months.
History of personal or family history of medullary thyroid cancer.
History of hypersensitivity to any of the components of the IdegLira combination.
Women in pregnancy, breastfeeding or absence of hormonal contraception.
Management for obesity with GLP1 receptor agonist.
Previous management with basal bolus scheme with total daily dose of insulin (DDT) greater than 70 U/day.
Patients with hyperglycemia associated with steroids.
Patients who are insulin users prior to current hospitalization and have an in-hospital HbA1c greater than 11%.

Sites

Hospital Universitario San Ignacio - Bogotá
Recruiting
Cra. 7 #40-62, Bogotá
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