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A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Plain-language guide to NCT05048719: phase 2 randomized trial of Dulaglutide, 383 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05048719
- Phase
- phase 2
- Status
- completed
- Start
- 2021-09-15
- Completion (planned or actual)
- 2022-09-30
- Participants
- 383 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Dulaglutide.
This study will last about 30 weeks.
The registry classes the interventions as drug.
Who Took Part
The registry lists 383 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 a stable body weight for the 3 months prior to randomization. Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²). Women not of childbearing potential (WNOCBP) may participate in this trial. Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: have type 1 diabetes mellitus (t1dm) or history of ketoacidosis or hyperosmolar coma; have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention; have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2021-09-15 with completion listed for 2022-09-30.
It ran at 44 sites in United States (20), Hungary (8), Poland (8), Slovakia (5) and Puerto Rico (3).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in HbA1c in LY3502970 as Compared to Placebo (time frame: Baseline, Week 26).
It also tracked 6 secondary outcomes, for example Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide, Change From Baseline in Fasting Serum Glucose and Change From Baseline in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Dulaglutide in 383 people.
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.