Liraglutide Hospital Discharge Trial

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Liraglutide.

It had two arms (groups): Liraglutide + OADs (experimental) and Glargine + OADs (active comparator).

Liraglutide once daily in combination to oral anti-diabetic agents (OADs).

Glargine once daily in combination to oral anti-diabetic agents (OADs).

The registry classes the interventions as drug.

More on the Plan

Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared to treatment with glargine (Lantus®) in patients with T2D after hospital discharge.

Who Took Part

273 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: Males or females between the ages of 18 and 80 years discharged after hospital admission from non- ICU general surgery and medicine services (excluding gastrointestinal and cardiac surgeries). BMI \> 25 Kg/m2 and ≤ 45 Kg/m2.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: age \< 18 or \> 80 years; subjects with a history of type 1 diabetes; treatment with insulin or glp-1 analogs during the past 3 months prior to admission.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-03 with completion listed for 2020-08-30.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic Control at Hospital Discharge and 6 Months Follow up (time frame: Hospital discharge, 6 months (26 weeks)).

It also tracked 14 secondary outcomes, for example Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks, Hypoglycemic Episodes, Change in Body Weight From Baseline, Change in BMI, Change in Cardiovascular Risk Factors: Blood Pressure and Cardiovascular Risk Factor: Heart Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Liraglutide in 273 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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