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A Study of IBI362 in Chinese Patients With Type 2 Diabetes
Plain-language guide to NCT04965506: phase 2 randomized trial of Mazdutide and Dulaglutide, 252 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04965506
- Phase
- phase 2
- Status
- completed
- Start
- 2021-09-06
- Completion (planned or actual)
- 2022-04-28
- Participants
- 252 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Mazdutide and Dulaglutide.
It had five arms (groups): one (experimental), one (experimental), Dulaglutide (active comparator), one (experimental) and placebo (placebo comparator).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 252 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999). Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: type 1 diabetes, special types of diabetes, or gestational diabetes; have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening; history of severe hypoglycemic episodes within 6 months prior to screening.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Mazdutide 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 Mazdutide.
Those kept unaware of assignments: participant and investigator.
It started in 2021-09-06 with completion listed for 2022-04-28.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: The change in HbA1c from baseline to 20 weeks (time frame: Baseline,20 weeks).
It also tracked 2 secondary outcomes, for example Number of participants with treatment-related adverse events.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Mazdutide and Dulaglutide in 252 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Mazdutide compound page and the Dulaglutide compound page, all human trials.
Our Notes on the Compounds
Mazdutide: A dual GLP-1 and glucagon receptor agonist with approvals announced in China for weight management and type 2 diabetes.
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.