← Human Trials & Peer-Reviewed Studies
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
Plain-language guide to NCT05564039: phase 4 randomized trial of Tirzepatide and Dulaglutide, 282 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05564039
- Phase
- phase 4
- Status
- completed
- Start
- 2022-11-30
- Completion (planned or actual)
- 2024-07-15
- Participants
- 282 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Tirzepatide and Dulaglutide.
It had two arms (groups): one (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
282 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 type 2 diabetes. Have BMI ≥25 kilogram/square meter (kg/m²).
The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: have type 1 diabetes; have a history of chronic or acute pancreatitis; have a history of.
How the Study Was Run
Design: 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.
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 2022-11-30 with completion listed for 2024-07-15.
It ran at 38 sites in United States (11), Mexico (9), Belgium (6), Germany (6) and Romania (6).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in HbA1c (time frame: Baseline, Week 40).
It also tracked 12 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Fasting Serum Glucose (FSG), Change From Baseline in Waist Circumference, Change From Baseline in Body Mass Index (BMI) and Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Tirzepatide and Dulaglutide in 282 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 Dulaglutide 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.
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
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.