Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

What Was Tested

This registered phase 1, phase 2 trial tested Mazdutide and Dulaglutide.

This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes.

The investigators and subjects will be blinded to the study drug IBI362 and placebo.

Dulaglutide will be used as an open-label active control group.

In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts.

Who Took Part

Enrollment: 42 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 or female 18 to 75 years of age at the time of consent. Body mass index 20 ≤ BMI ≤ 35 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: type 1 diabetes, special types of diabetes, or gestational diabetes; ketoacidosis or lactic acidosis within 6 months prior to screening; history of severe hypoglycaemic episodes within 6 months prior to screening.

How the Study Was Run

Design: randomized, sequential and double-blind.

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

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2020-09-12 with completion listed for 2021-05-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo.

It also tracked 8 secondary outcomes, for example The PK/PD parameters of IBI362 in patients with T2DM, Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM, Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM, Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM, Evaluate the Glucagon of IBI362 in patients with T2DM and Evaluate the Insulin of IBI362 in patients with T2DM.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Mazdutide and Dulaglutide in 42 people.

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

More context: the Mazdutide compound page and the Dulaglutide compound page, all human trials.