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Clinical Trial Details

Trial ID: L2047
Source ID: NCT05036876
Associated Drug: Degludec
Title: Degludec Glargine U300 Hospital Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Degludec|DRUG: Glargine U300
Outcome Measures: Primary: Change in mean daily blood glucose concentration in hospitalized patients, Blood glucose will be measured before each meal, bedtime and at 3:00 am. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U-300 once daily plus aspart insulin before meals., The first 7 days of therapy | Secondary: Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals in hospitalized patients, Blood glucose will be measured before each meal, bedtime and at 3:00 am, and proportion of basic glucose readings between 70 mg/dl and 180 mg/dl will be recorded., The first 7 days of therapy|Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients, Blood glucose will be measured before each meal, bedtime and 3:00 am, and number of hypoglycemic episodes (\< 70 mg/dl and 54 mg/dl) will be recorded, The first 7 days of therapy|Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients, Blood glucose will be measured before each meal, bedtime and at 3:00 am, and number of hypoglycemia (\< 54 mg/dl) episodes will be recorded, The first 7 days of therapy|Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients, Blood glucose will be measured before each meal, bedtime and at 3:00 am, and number of severe hyperglycemia (\> 240 mg/dl) episodes will be recorded, The first 7 days of therapy|Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients, The study team will document day and time of insulin administration of study drug given once daily and prandial- rapid-acting insulin (aspart) given before meals. The study team will also record dose and number of units given as supplement (correction) to correct hyperglycemia, The first 7 days of therapy|Average blood glucose (mg/dL), percentage time in target, percentage time below target, and percentage time above target in a subgroup of study participants., A subgroup of participants (n = 100) will be monitored using continuous glucose monitoring system (CGMS) (FreeStyle Libre)., The first 7 days of therapy
Sponsor/Collaborators: Sponsor: Medanta, The Medicity, India
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 220
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-10-10
Completion Date: 2022-03-01
Results First Posted:
Last Update Posted: 2024-12-09
Locations: Division Of Endocrinology and Diabetes , Medanta The Medicity Hospital, Gurgaon, Haryana, 122001, India
URL: https://clinicaltrials.gov/show/NCT05036876