Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus

What Was Tested

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

To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

It had two arms (groups): Dapagliflozin combined with CSII (experimental) and CSII alone (active comparator).

Aspart infused by CSII alone as glucose lowering therapy.

The registry classes the interventions as drug.

More on the Plan

To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

Who Took Part

Enrollment: 100 planned participants were the target.

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: Volunteer to participate and be able to sign informed consent prior to the trial. Patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old. No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: patients with insulin allergy; drug abuse and alcohol dependence in the past 5 years; systemic hormone therapy was used in the last three months.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Insulin Aspart was given.

Those kept unaware of assignments: participant.

It started in 2019-10-01 with completion listed for 2019-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the effect of dapagliflozin combined with CSII on glucose profile (time frame: 5 weeks).

It also tracked 3 secondary outcomes, for example the effects of dapagliflozin combined with CSII on weight, the effects of dapagliflozin combined with CSII on blood pressure and the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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