A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Tirzepatide and Dulaglutide.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 636 actual participants took part.

It was open to people of any sex aged from 20 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 based on the World Health Organization classification before the screening visit. Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:. Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.

The full record lists 6 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 immediate or urgent treatment.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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 2019-05-07 with completion listed for 2021-03-10.

It ran at 46 sites in Japan (46).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 52).

It also tracked 11 secondary outcomes, for example Change From Baseline in Fasting Serum Glucose, Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values, Change From Baseline in Body Weight, Change From Baseline in Fasting Insulin, Change From Baseline in Fasting C-Peptide and Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Dulaglutide in 636 people.

With 636 participants it is a large trial for this field.

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

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