Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico.

Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2.

It had two arms (groups): DPP4 inhibitor + insulin (experimental) and Insulin scheme alone (active comparator).

Patients assigned to this group will receive only a basal-bolus insulin scheme.

The registry classes the interventions as drug.

More on the Plan

For this purpose the researchers will randomize patients with SARS-CoV-2 and hyperglycemia to receive either the combination of DPP4i + insulin or insulin alone and will follow al algorithm treatment to define metabolic control as well as prognosis.

Who Took Part

The registry lists 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Patients accepting oral medications. Older than 18 years of age. Patients who accept to participate in the study and sign the consent form.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: type 1 diabetes; hyperosmolar hyperglycemic state or diabetic ketoacidosis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2020-08-01 with completion listed for 2021-02-28.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucose levels (time frame: 5-10 days). Number of patients who achieve metabolic control (time frame: 5-10 days).

It also tracked 2 secondary outcomes, for example Number of patients who die or need mechanical ventilation and C reactive protein levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 70 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.