Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had two arms (groups): Dapagliflozin group (active comparator) and Placebo group (placebo comparator).

50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.

50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures.

The registry classes the interventions as drug.

More on the Plan

Inclusion Criteria: Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified inclusion criterion with respect to heart failure etiology and/or ejection fraction.

Other etiologies of fluid overload different from heart failure. 2.

Unstable patients: acute coronary syndrome, cardiogenic shock . 4.

Patients requiring inotropic agents or renal dialysis. 5.

Who Took Part

100 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: other etiologies of fluid overload different from heart failure; unstable patients: acute coronary syndrome, cardiogenic shock ; patients requiring inotropic agents or renal dialysis.

How the Study Was Run

Design: randomized, sequential and double-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2020-05-01 with completion listed for 2020-12-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in body weight measurement (Diuresis effect.) (time frame: Days of admission (3-5 days)). Diuresis effect (time frame: Days of admission (3-5 days)).

It also tracked 2 secondary outcomes, for example Renal function and Patient-reported dyspnea will be assessed with the use five point Linker scale.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 100 people.

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

More context: the Insulin (regular human) compound page, all human trials.