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A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Plain-language guide to NCT04809220: phase 3 randomized trial of Dulaglutide, 591 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04809220
- Phase
- phase 3
- Status
- completed
- Start
- 2021-04-13
- Completion (planned or actual)
- 2022-10-01
- Participants
- 591 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Hypoglycemic Agents
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Dulaglutide.
The study duration is approximately 58 weeks.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 591 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification. Have the following HbA1c result at screening. Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \<35 kg/m² at Day 1.
The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: have type 1 diabetes (t1d); have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma; have had any myocardial infarction (mi), heart failure or cerebrovascular accident (stroke).
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Dulaglutide group and the comparison group ran side by side rather than switching.
As a double-blind Dulaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2021-04-13 with completion listed for 2022-10-01.
It ran at 44 sites in Japan (44).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (time frame: Baseline, Week 26).
It also tracked 5 secondary outcomes, for example Change From Baseline in HbA1c at Week 52, Change From Baseline in Fasting Serum Glucose (FSG), Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG) and Change From Baseline in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Dulaglutide in 591 people.
With 591 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 Dulaglutide compound page, all human trials.
Our Notes on the Compound
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.