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A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Plain-language guide to NCT03951753: phase 1 randomized trial of Tirzepatide and Semaglutide, 117 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03951753
- Phase
- phase 1
- Status
- completed
- Start
- 2019-06-28
- Completion (planned or actual)
- 2021-04-08
- Participants
- 117 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Tirzepatide and Semaglutide.
This is a study for participants with type 2 diabetes mellitus.
The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal.
The study will last up to 40 weeks, including a 28-week treatment period.
It had three arms (groups): one (experimental), one (active comparator) and Placebo (placebo comparator).
Participants received Placebo administered SC once weekly for 28 weeks.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 117 actual participants took part.
It was open to people of any sex aged from 20 years up to 74 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have T2DM for at least 6 months.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.
Those kept unaware of assignments: participant and investigator.
It started in 2019-06-28 with completion listed for 2021-04-08.
It ran at 2 sites in Germany (2).
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Change From Baseline in Total Clamp Disposition Index (cDI) (time frame: Baseline, Week 28).
It also tracked 8 secondary outcomes, for example Change From Baseline in Fasting Glucose, Change From Baseline in Postmeal Glucose, Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min), Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value and Change From Baseline in Glucagon Concentration at Fasting.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Tirzepatide and Semaglutide in 117 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 and the Semaglutide compound page, all human trials.
Our Notes on the Compounds
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
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.