A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Dulaglutide.

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

The registry classes the interventions as drug.

Who Took Part

737 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: Type 2 diabetes mellitus. OAM-naïve or have been taking OAM monotherapy for at least 3 months. Adult men or adult non-pregnant, non-breastfeeding women. Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m\^2).

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have previously been treated with a glucagon-like peptide-1 (glp-1) receptor agonist, glp-1 analog, or any other incretin mimetic during the 3 months before screening; are currently taking dipeptidylpeptidase-iv (dpp-iv) inhibitor and thiazolidinediones (tzd) during the 3 months before screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, care provider and investigator.

It started in 2012-07 with completion listed for 2014-08.

It ran at 30 sites in China (21), Taiwan (6) and South Korea (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c at 26 Weeks (time frame: Baseline, 26 Weeks).

It also tracked 20 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks, Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks, Rate of Hypoglycemic Episodes, Number of Participants With Self-Reported Hypoglycemic Episodes, Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks and Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 737 people.

With 737 participants it is a large trial for this field.

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.