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

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Dulaglutide.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 774 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 mellitus for at least 6 months. Adult men or adult non-pregnant, non-breastfeeding women. Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m\^2).

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have previous treatment with a glucagon-like peptide-1 (glp-1) receptor agonist, glp-1 analog, or any other incretin mimetic; have treatment with dipeptidyl peptidase-iv (dpp-iv) inhibitor, an alpha-glucosidase inhibitor (agi), thiazolidinedione (tzd), or glinide.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

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

It ran at 30 sites in China (20), Russia (4), South Korea (4) and Mexico (2).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 21 secondary outcomes, for example Change From Baseline in HbA1c at 52 Weeks, Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks, Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks, Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks, Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks and Rate of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Dulaglutide in 774 people.

With 774 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 Insulin Glargine compound page and the Dulaglutide compound page, all human trials.