Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7167
Source ID: NCT05457933
Associated Drug: Dapagliflozin
Title: Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2diabetes|Coronary Artery Disease
Interventions: DRUG: Dapagliflozin|DRUG: Glargine
Outcome Measures: Primary: Noninferiority in mean differences between groups in their daily blood glucose concentrations, Blood glucose will be measured pre-breakfast, pre-lunch, pre-dinner and night-time (0300 hours). Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with dapagliflozin 10 mg plus basal-bolus insulin or basal-bolus regimen, using glargine U300 as basal insulin and insulin lispro U100 before meals., The first 7 days of therapy in hospital and 5 days post-discharge | Secondary: Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals and night-time in hospitalized patients., Blood glucose will be measured before each meal and at night-time (0300 hours), and proportion of basic glucose readings between 70 mg/dl and 180 mg/dl will be recorded., The first 7 days of therapy in hospital and 5 days post-discharge.|Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients., Blood glucose will be measured before each meal and at night-time (0300 hours), and number of hypoglycemic episodes (\< 70 mg/dl and 54 mg/dl) will be recorded., The first 7 days of therapy in hospital and 5 days post-discharge.|Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients., Blood glucose will be measured before each meal and at night-time (0300 hours, and number of hypoglycemia (\< 54 mg/dl) episodes will be recorded., The first 7 days of therapy in hospital and 5 days post-discharge|Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients., Blood glucose will be measured before each meal and at night-time (0300 hours, and number of severe hyperglycemia (\> 240 mg/dl) episodes will be recorded., The first 7 days of therapy in hospital and 5 days post-discharge.|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 (lispro U100) 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 in hospital and 5 days post-discharge.|Continuous Glucose Monitoring, Average blood glucose (mg/dL), percentage time in target (TIR), percentage time below target (TBR), and percentage time above target (TAR) in a subgroup of study participants using professional, blinded continuous glucose monitoring system (CGMS)., The first 7 days of therapy in hospital and 5 days post-discharge.|Hospital complications, Hospital complications will be documented in all patients: complications like mortality, sternal wound infections, acute kidney injury, consolidation/pneumonia/pleural effusion, stroke and cardiac arrthymias., The first 7 days of therapy in hospital and 5 days post-discharge.|Serum Ketone levels, Differences in number of patients who develop ketonemia. \[Serum ketone body levels will be performed in all patients at day of randomization (day 0), day 3 and Day 5 of randomization., Day 0, 3 and 5 of randomization|Diabetic acidosis, Differences in number of patients who develop acidosis. \[Venous blood gas (VBG) assessment in all patients with ketonemia\]., The first 7 days of therapy in hospital and 5 days post-discharge.|Glycated hemoglobin, Glycated hemoglobin will be re-assessed at 3-month, 3 Months|Fasting blood glucose, fasting blood glucose will be re-assessed at 3-month, 3 Months|Complete blood count, Complete blood count will be re-complete blood count assessed at 3-month, 3 Months|Liver function test, liver function test will be re-assessed at 3-month, 3 Months|Kidney function test, kidney function test will be re-assessed at 3-month, 3 Months|A Composite of re-admission for heart failure or for any other reason, Clinical complications namely re-admission for heart failure, or re-admission for any other reason will be re-assessed in all patients at 3-month., 3 Months|Diuretics Use, Dose of diuretics will be documented in all patients at 3-month., 3 Months
Sponsor/Collaborators: Sponsor: Medanta, The Medicity, India
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 250
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-29
Completion Date: 2023-01-14
Results First Posted:
Last Update Posted: 2023-10-19
Locations: Division Of Endocrinology and Diabetes, Medanta The Medicity, Gurgaon, Haryana, 122001, India
URL: https://clinicaltrials.gov/show/NCT05457933