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A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

Plain-language guide to NCT05691712: phase 3 randomized trial of Tirzepatide, 257 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05691712
Phase
phase 3
Status
completed
Start
2023-02-05
Completion (planned or actual)
2024-07-01
Participants
257 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Diabetes Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.

The registry classes the interventions as drug.

Who Took Part

The registry lists 257 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Have type 2 diabetes mellitus (T2DM). Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days. Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²).

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: have type 1 diabetes mellitus (t1dm); have a history of chronic or acute pancreatitis; have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind 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.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-02-05 with completion listed for 2024-07-01.

It ran at 25 sites in China (25).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Mean Change From Baseline in Body Weight, Mean Change From Baseline in Fasting Serum Glucose and Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 257 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.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.