A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Dulaglutide.

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

It had five arms (groups): LY2189265 + Sulfonylureas (SU) (experimental), LY2189265 + Biguanides (BG) (experimental), LY2189265 + alpha-glucosidase inhibitor (a-GI) (experimental), LY2189265 + Thiazolidinedione (TZD) (experimental) and LY2189265 + Glinides (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 394 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants who have had a diagnosis of type 2 diabetes mellitus before screening. Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: participants who have a diagnosis of type 1 diabetes; participants who have previously been treated with any other glucagon-like peptide-1 (glp-1) analog within the 3 months before screening; participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening.

How the Study Was Run

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

The Dulaglutide group and the comparison group ran side by side rather than switching.

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

It started in 2011-11 with completion listed for 2013-12.

It ran at 14 sites in Japan (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through 52 Weeks). Percentage of Participants With Hypoglycemic Episodes (time frame: Baseline through 52 Weeks).

It also tracked 6 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (HbA1c), Change From Baseline in Fasting Blood Glucose (FBG), Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG), Change From Baseline in Body Weight and Change From Baseline in Updated Homeostasis Model Assessment (HOMA2).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Dulaglutide in 394 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.