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A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
Plain-language guide to NCT04591626: phase 3 randomized trial of Insulin Glargine and Dulaglutide, 291 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04591626
- Phase
- phase 3
- Status
- completed
- Start
- 2020-12-07
- Completion (planned or actual)
- 2022-04-28
- Participants
- 291 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine and Dulaglutide.
The registry classes the interventions as drug.
Who Took Part
The registry lists 291 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. Are men or nonpregnant women aged ≥18 years at screening. Have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening. Have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening.
The full record lists 8 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 a history of severe hypoglycemia and/or hypoglycemia unawareness within the 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 Insulin Glargine group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2020-12-07 with completion listed for 2022-04-28.
It ran at 27 sites in China (27).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 28).
It also tracked 8 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Fasting Serum Glucose (FSG) and Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Dulaglutide in 291 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Glargine compound page and the Dulaglutide compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.