Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to examine whether treatment with dapagliflozin plus insulin as compared with insulin alone (basal-bolus insulin) will result in similar blood glucose control and similar rate of complications in patients with diabetes, who are admitted to a hospital in a noncritical setting

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medanta, The Medicity, India
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Males or females 30 years or above admitted to the hospital for elective CABG surgery

2. A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy.

3. Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 12 units per day.

4. Signed, informed consent prior to any study procedures

Exclusion Criteria:

1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).

2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.

3. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.

4. Patients treated with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).

5. Any known hypersensitivity to dapagliflozin.

6. History of recurrent urinary tract infections (>2 episodes) requiring antibiotic therapy in the last 1 year.

7. History of intolerance to dapagliflozin or any other sodium-glucose cotransporter 2 inhibitors.

8. Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension).

9. Patients with ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day).

10. Patients with impaired renal function (eGFR <45 ml/min/1.73m2).

11. Patients with congestive heart failure (NYHA- IV).

12. Patients with medical and surgical pancreatic disease.

13. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study