Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

What Was Tested

This registered phase 3 trial tested Dulaglutide.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.

Who Took Part

The registry lists 908 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: Participant must be greater than or equal to (\>=) 18 years of age at the time of signing the informed consent. Participants with T2DM. Diabetes diagnosed at least 1 year before screening.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy; personal or family history of medullary thyroid cancer (mtc) or genetic conditions that predisposes to mtc (e.g., multiple endocrine neoplasia syndromes); body weight change of greater than or equal to (\>=) 5 kilogram within the last 3 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Dulaglutide study: the participants and staff both knew the treatment.

It started in 2018-09-26 with completion listed for 2020-10-13.

It ran at 45 sites in United States (30), Poland (6), Hungary (5) and Ukraine (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to Week 56 in HbA1c (time frame: Baseline to Week 56).

It also tracked 5 secondary outcomes, for example Change From Baseline to Week 56 in Body Weight and Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 908 people.

With 908 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Dulaglutide compound page, all human trials.