Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Exenatide.

It had two arms (groups): PB-119 injection (experimental) and Exenatide Injection (Byetta) (active comparator).

The registry classes the interventions as biological.

More on the Plan

Subject Number：18 subjects will be randomized to each group, with equal number of females and males. 12 subjects will be in PB-119 group, 6 subjects will be in exenatide group.

Who Took Part

36 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/or female subjects between the ages of 18\~45 (inclusive) years, the ratio of females to males is approximately 1:1;. Female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19\~30 kg/m2 (inclusive);. Subject can understand the procedures and methods of this clinical trial, is willing to participate and sign the written informed consent;.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: subject was diagnosed as type 1 diabetes; subject has acute complications of diabetes, such as ketoacidosis or hyperosmolar coma within 6 months before screening;; subject who is allergic to exenatide, investigational drug or any ingredients (citric acid, mannitol, m-cresol); or have specific severe drug allergy history.

How the Study Was Run

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

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2015-04-08 with completion listed for 2016-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of treatment-emergent AE (safety and tolerability) (time frame: the change form base line lab values at 3 months).

It also tracked 1 secondary outcome, for example PB-119 blood concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 36 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 Exenatide compound page, all human trials.