A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Liraglutide.

A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus.

It had three arms (groups): Cohort A (experimental), Cohort B (experimental) and Cohort C (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 44 planned participants were the target.

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

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

Examples of who could join: Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit. History of type 2 diabetes. Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit. Use of approved methods of contraception. Ability to provide written informed consent.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes; systolic blood pressure \>160 mm hg and/or diastolic blood pressure \>100 mm hg at screening; pregnant or lactating women.

How the Study Was Run

The set-up was 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.

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, care provider, investigator and outcomes assessor.

It started in 2013-12 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PK profile of acetaminophen (time frame: 13 weeks).

It also tracked 2 secondary outcomes, for example Glucose metabolism and Safety and tolerability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 44 people.

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

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