A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

What Was Tested

This registered phase 3 trial tested Tirzepatide.

Participants will administer tirzepatide or placebo along with their previous glucose lowering medications.

The study will last approximately 47 weeks and may include about 23 visits.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

475 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit. Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry; have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.

How the Study Was Run

Design: randomized, parallel-group 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.

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

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 2019-08-30 with completion listed for 2020-12-22.

It ran at 48 sites in Germany (10), Japan (10), Czechia (7), United States (5), Slovakia (5) and Spain (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) ([amount hidden]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 475 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.