Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Dulaglutide.

The registry classes the interventions as drug.

More on the Plan

Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives.

These secondary objectives will be used to compare the effect of the experimental compound and placebo.

Maximum of 9 study visits are planned.

Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections.

Who Took Part

Enrollment: 167 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diabetes mellitus, type 2. Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication. Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening). Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Stable weight for 3 months prior to screening.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: diabetes mellitus, type 1; taking any glucose-lowering oral agents other than metformin within 3 months prior to screening; use of medications (prescription or over-the counter) to promote weight loss.

How the Study Was Run

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

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.

Neither the participants nor the staff measuring them knew who was on Dulaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-12 with completion listed for 2010-01.

It ran at 46 sites in United States (12), India (7), Denmark (6), Spain (6), Croatia (4) and Russia (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 12 weeks).

It also tracked 16 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (HbA1c), Change From Baseline in Fasting Blood Glucose, Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles, Change From Baseline in Beta-cell Function (HOMA2-%B), Change From Baseline in Insulin Sensitivity (HOMA2-%S) and Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 167 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.