To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

This study is the first administration of GSK2890457 in humans.

It had six arms (groups): Part A - GSK2890457 (experimental), Part B - GSK2890457 + Liraglutide (experimental), Part C - GSK2890457 + Metformin (experimental), Part A - Placebo (placebo comparator) and Part B - Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 53 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 14 inclusion and 13 exclusion criteria; among the exclusions: positive test for hiv, hepatitis b, or hepatitis c at screening; presence of or symptoms of an active infection; uncorrected thyroid dysfunction.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-02-10 with completion listed for 2013-09-12.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Any Hypoglycemic Events During Part A (time frame: Up to Follow-up (8 weeks)). Number of Participants With Any Hypoglycemic Events During Part B and Part C (time frame: Up to Follow-up (8 weeks)). Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A (time frame: Baseline (Day 1, Randomization) up to Day 42).

It also tracked 9 secondary outcomes, for example Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B, Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B, Cmax of Metformin During the Double-blind Treatment Period of Part A, Tmax of Metformin During the Double-blind Treatment Period of Part A, Cmax of Metformin During the Double-blind Treatment Period of Part C and Tmax of Metformin During the Double-blind Treatment Period of Part C.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 53 people.

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

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