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

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

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.

It had two arms (groups): Dapagliflozin group (experimental) and Basal-bolus group (active comparator).

The registry classes the interventions as drug.

More on the Plan

The role of SGLT-2 inhibitors in the treatment of patients admitted to hospital in a non-critical care setting has not been assessed.

Both arms will receive glargine U300 as basal insulin and lispro U100 as rapid-acting bolus insulin.

Principal Investigator do not expect any attrition rate.

Procedures Patients will be treated with a basal-bolus insulin regimen approach as previously reported.

Who Took Part

250 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females 30 years or above admitted to the hospital for elective CABG surgery. A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy. Signed, informed consent prior to any study procedures.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria; patients treated with long-acting weekly glp1-ra (weekly exenatide, or dulaglutide); any known hypersensitivity to dapagliflozin.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-07-29 with completion listed for 2023-01-14.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 16 secondary outcomes, for example Continuous Glucose Monitoring, Hospital complications, Serum Ketone levels, Diabetic acidosis, Glycated hemoglobin and Fasting blood glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 250 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.