A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide.

The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia).

The study is open to participants with type 2 diabetes.

It will last about 42 weeks for each participant.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants received placebo QW administered SC in one of two study periods.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 42 actual participants took part.

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: Have type 2 diabetes mellitus (T2DM) for at least 1 year. Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m²) inclusive, at screening.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

Each person switched between Tirzepatide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2020-02-24 with completion listed for 2022-01-25.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 42 people.

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

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