Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

The DUAL (Dual Action of Liraglutide and Insulin Degludec) studies are the pivotal studies of this combination.

It had two arms (groups): basal group bolus (active comparator) and insulin degludec + liraglutide ( ideglira) (experimental).

The registry classes the interventions as drug.

More on the Plan

This includes consideration of key patient factors: 1) important comorbidities, such as atherosclerotic cardiovascular disease, high-risk indicators of cardiovascular, chronic kidney disease, and heart failure, 2) risk of hypoglycemia, 3) effects on body weight, 4) side effects, 5) cost, and 6) patient preferences.

With these considerations in mind, drug therapy should be initiated in conjunction with a lifestyle modification consultation focused on diet and physical activity.

In recent years, two combinations of basal insulin with GLP-1 analog received regulatory approval from the European Medicines Agency and the U.S.

Food and Drug Administration Agency.

Who Took Part

66 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: patient with diagnosis or suspicion of dm1; inability of the patient or family member to continue injectable therapy at home; history of chronic or acute pancreatitis in the last 3 months.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2022-12-01 with completion listed for 2023-08-30.

It ran at 1 site in Colombia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To compare the percentage of hypoglycemia (time frame: 4 weeks).

It also tracked 7 secondary outcomes, for example Compare episodes of severe hypoglycemia, Compare the metrics of glycemic control, Compare the incidence density of hypoglycemia, compare the percentage of patients without episodes of hypoglycemia, HbA1c change and To assess whether there is a difference in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 66 people.

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

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