Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

What Was Tested

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

It had two arms (groups): liraglutide plus insulin (experimental) and Insulin titration only (active comparator).

Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.

Patients were randomized to receive insulin only (control) for 6 months. The controls were then crossed over to receive liraglutide plus insulin for 6 months after the initial control period.

The registry classes the interventions as drug.

More on the Plan

Primary endpoint to be compared between groups will be HbA1c at 6 months.

Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.

Who Took Part

Enrollment: 37 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: Aged 18 to 80 years. Females of child-bearing potential must be using adequate form of contraception. Patient willing to monitor BG four times daily, use CGM, and comply with study-related protocol.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: use of any glp-1 receptor agonist within previous three months; use of dpp-4 inhibitors or oral insulin secretagogues within the previous three months; use of glucocorticoids (except inhaled).

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2011-12 with completion listed for 2013-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in HbA1c at six months (time frame: baseline and six months).

It also tracked 4 secondary outcomes, for example Hypoglycemia, Weight and GlycoMark.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Liraglutide in 37 people.

Its size is small, so on its own it can only give an early look.

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 and the Liraglutide compound page, all human trials.