← Human Trials & Peer-Reviewed Studies
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
Plain-language guide to NCT02973100: phase 2 randomized trial of Dulaglutide, 318 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02973100
- Phase
- phase 2
- Status
- completed
- Start
- 2016-12
- Completion (planned or actual)
- 2017-07-15
- Participants
- 318 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Dulaglutide.
It had four arms (groups): one (experimental), one (experimental), one (active comparator) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
318 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 had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification. Have a body mass index (BMI) ≥25 kilograms per square meter.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.
The Dulaglutide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.
Those kept unaware of assignments: participant and investigator.
It started in 2016-12 with completion listed for 2017-07-15.
It ran at 66 sites in United States (38), Poland (10), Czechia (6), Mexico (5), Romania (5) and Puerto Rico (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 18).
It also tracked 7 secondary outcomes, for example Change From Baseline in Fasting Serum Glucose (FSG), Change From Baseline in Body Weight, Percentage of Participants Discontinuing Study Drug Due to Adverse Events and Rate of Documented Symptomatic Hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Dulaglutide in 318 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.