A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

What Was Tested

In this phase 3 trial, researchers set out to test Tirzepatide and Insulin Glargine.

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 917 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: Type 2 diabetes mellitus. Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions). Body mass Index (BMI) ≥23 kilograms per meter squared.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes mellitus; have history of chronic or acute pancreatitis; have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-12-09 with completion listed for 2021-11-01.

It ran at 67 sites in China (43), South Korea (13), Australia (7) and India (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Change From Baseline in Hemoglobin A1c (HbA1c) ([amount hidden]).

It also tracked 9 secondary outcomes, for example Mean Change From Baseline in Body Weight, Mean Change From Baseline in Fasting Serum Glucose and Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Insulin Glargine in 917 people.

With 917 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 Insulin Glargine compound page, all human trials.