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A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Plain-language guide to NCT03882970: phase 3 randomized trial of Tirzepatide, 1444 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03882970
- Phase
- phase 3
- Status
- completed
- Start
- 2019-04-01
- Completion (planned or actual)
- 2020-12-11
- Participants
- 1444 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Tirzepatide.
The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes.
The study will last about 67 weeks and may include up to 22 visits.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and Insulin Degludec (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 1444 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). Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening.
The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: participants must not:; have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
Being open-label, the Tirzepatide study did not mask who received what.
It started in 2019-04-01 with completion listed for 2020-12-11.
It ran at 122 sites in United States (33), Greece (10), Romania (10), South Korea (10), Argentina (9) and Taiwan (9).
Its stated primary purpose is treatment.
What Was Measured
The main thing 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 1444 people.
With 1444 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, 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.