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Clinical Trial Details

Trial ID: L4910
Source ID: NCT05767255
Associated Drug: Insulin Degludec + Liraglutide
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
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2 Treated With Insulin
Interventions: DRUG: insulin degludec + liraglutide|DRUG: Insulin Glargine - Insulin Aspart
Outcome Measures: Primary: To compare the percentage of hypoglycemia, To compare the percentage of patients presenting at least one episode of hypoglycemia (defined as one or more episodes of hypoglycemia below 54 mg/ dL for more than 20 minutes by continuous flash glucose monitoring), between the basal bolus group and the degludec/liraglutide (ideglira) group in the first four weeks after hospital discharge., 4 weeks | Secondary: Compare episodes of severe hypoglycemia, To compare episodes of severe hypoglycemia between the two groups; defined as episodes with altered state of consciousness or requiring assistance from another person to make corrective decisions., 4 weeks|Compare the metrics of glycemic control, To compare the metrics of glycemic control (time in range 70-180 mg/dL, time above range 180 mg/dL, time above 250 mg/dL , GMI, coefficient of variation ) of the two groups., 4 weeks|Compare the incidence density of hypoglycemia, To compare the incidence density of hypoglycemia defined as the number of hypoglycemia events (readings below 54 mg/ dL for more than 20 minutes by continuous flash glucose monitoring) in each intervention group., 4 weeks|compare the percentage of patients without episodes of hypoglycemia, To compare the percentage of patients achieving a time in range greater than 70% without episodes of hypoglycemia in each intervention group., 4 weeks|HbA1c change, To evaluate the efficacy of the schemes according to Hbac1 metrics before randomization., 4 weeks|To assess whether there is a difference in body weight, To assess whether there is a difference in body weight change according to treatment allocation arm., 4 weeks|Evaluate associated adverse effects, Evaluate and compare associated adverse effects such as: nausea, emesis, abdominal distension, diarrhea, constipation, epigastric pain, early satiety, postprandial fullness, weight gain, acute pancreatitis, symptomatic cholelithiasis, diabetic ketoacidosis, hyperosmolar state (see attached operational definitions).They will be evaluated by means of the CTCAE manual version 5.0., 4 weeks
Sponsor/Collaborators: Sponsor: Hospital Universitario San Ignacio
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-12-01
Completion Date: 2023-08-30
Results First Posted:
Last Update Posted: 2023-03-14
Locations: Hospital Universitario San Ignacio, Bogotá, Colombia
URL: https://clinicaltrials.gov/show/NCT05767255