Efficay and Safety of Empagliflozin Versus Sitagliptin for the In-patient Management of Hyperglycemia

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical guidelines from professional organizations have recommended the use of multidose insulin regimens as the preferred therapy for glycaemic control in patients admitted to hospital in a non-intensive-careunit setting. The use of a basal-bolus regimen with a once daily basal insulin and rapid-acting insulin analogs before meals has been shown to improve glycaemic control and to reduce the rate of hospital complications in general medical and surgical patients with type 2 diabetes.The basal-bolus regimen however is labour intensive, requiring several insulin injections, and is associated with a high risk of hypoglycaemia. Hypoglycaemia has been reported in 12% to 32% of patients in general medicine and surgery with type 2 diabetes treated with basal-bolus insulin regimens.Because of these limitations, alternative treatment regimens are needed that could improve glycaemic control and clinical outcomes, while facilitating care and minimising the risk of hypoglycaemia in patients with diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medanta, The Medicity, India
• Collaborator: Diabetes & Endocrinology Foundation
• Treatments: Empagliflozin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

Patients aged 18-years and above with type 2 diabetes and a random blood glucose concentration of 140-400 mg/dL who were being treated with diet or oral antidiabetic drugs or had a total daily insulin dose of 0•6 units per kg or less, admitted to general medicine or surgery

Exclusion Criteria:

Patients with a blood glucose concentration greater than 400mg/dL or with current or previous history of diabetic ketoacidosis,

Type 1 diabetes,

Hyperglycaemia without a known history of diabetes

Patients expected to be without oral intake for more than 48 h

Patients admitted to or expected to require admission to an intensive care unit

Clinically relevant hepatic disease or impaired renal function [eGFR] <30 mL/min per 1•73 m²)

Pregnancy, and any mental health condition rendering the patient unable to give informed consent

Current or recurrent uti(more than 2 times in last 6 months)