| Trial ID: | L6389 |
| Source ID: | NCT06187285
|
| Associated Drug: |
Empagliflozin 25 Mg
|
| Title: |
Efficay and Safety of Empagliflozin Versus Sitagliptin for the In-patient Management of Hyperglycemia
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Empagliflozin 25 MG|DRUG: Sitagliptin 100mg
|
| Outcome Measures: |
Primary: Mean blood glucose concentration, Blood glucose will be measured pre-breakfast, pre-lunch, pre-dinner and bed time. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with empagliflozin 25 mg (Empa Group) or sitagliptin 100 mg (Sita Group). Both groups will receive basal insulin and/or supplemental bolus insulin, The first 7 days of therapy in hospital | Secondary: Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals and bed time in hospitalized patients, The first 7 days of therapy in hospital|Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients., The first 7 days of therapy in hospital|Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients, The first 7 days of therapy in hospital|Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients., The first 7 days of therapy in hospital|Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients., The first 7 days of therapy in hospital|Hospital complications, The first 7 days of therapy in hospital|ketonemia, The first 7 days of therapy in hospital|Diabetic acidosis, The first 7 days of therapy in hospital|Glycated hemoglobin, The first 7 days of therapy in hospital
|
| Sponsor/Collaborators: |
Sponsor: Medanta, The Medicity, India | Collaborators: Diabetes & Endocrinology Foundation
|
| 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: |
2024-01-01
|
| Completion Date: |
2025-06-01
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| Results First Posted: |
|
| Last Update Posted: |
2024-01-05
|
| Locations: |
Division Of Endocrinology & Diabetes, Medanta The Medicity, Gurgaon, Haryana, 122001, India
|
| URL: |
https://clinicaltrials.gov/show/NCT06187285
|
