A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Tirzepatide.

The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

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

The registry classes the interventions as drug.

Who Took Part

443 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 body mass index (BMI) of ≥23 kilograms per meter squared at screening.

The full record lists 5 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

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2019-03-30 with completion listed for 2021-01-26.

It ran at 34 sites in Japan (34).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 52).

It also tracked 12 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in Fasting Serum Glucose, Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values, Change From Baseline in Body Weight, Change From Baseline in Fasting Insulin and Change From Baseline in Fasting C-Peptide.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 443 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.