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A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
Plain-language guide to NCT05659537: phase 4 interventional trial of Dulaglutide, 212 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05659537
- Phase
- phase 4
- Status
- completed
- Start
- 2022-12-29
- Completion (planned or actual)
- 2024-01-16
- Participants
- 212 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Dulaglutide.
The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.
It had 1 arm (groups): Dulaglutide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 212 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 body mass index (BMI) ≥ 23 kilogram/square meter (kg/m²).
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM; participants have known hypersensitivity or allergy to dulaglutide or its excipients; participants are on systemic steroids for any period of more than 14 days.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-12-29 with completion listed for 2024-01-16.
It ran at 7 sites in India (7).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events (time frame: Baseline through Follow-up (up to 28 weeks)). Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 (time frame: Baseline through Week 24). Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24 (time frame: Baseline through Week 24).
It also tracked 1 secondary outcome, for example Mean Change in HbA1c From Baseline to Week 24.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Dulaglutide in 212 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.