Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

It had seven arms (groups): Diet and Exercise (experimental), Metformin (experimental), Sulfonylurea (experimental), Metformin and Sulfonylurea (experimental) and PB1023 (experimental).

Diet and exercise only.

Metformin only.

Sulfonylurea only.

The registry classes the interventions as drug and other.

Who Took Part

593 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: Male and female subjects 18 to 75 years of age, inclusive;. Body mass index ≤45 kg/m2;.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (glp-1) receptor analog/agonist;; unstable cardiovascular disease;; history of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of glp-1 receptor agonists;.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2012-07 with completion listed for 2013-07.

It ran at 93 sites in United States (93).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator and Describe the frequencies of adverse events in the treatment groups.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 593 people.

With 593 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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