A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Exenatide.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo/placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

153 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Diagnosed with type 2 diabetes. Have a body weight of \>=50 kg.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: have participated in this study previously, or any other study using exenatide or other glp-1 analogs; are treated with any exogenous insulin within 3 months of screening; have characteristics contraindicating for concomitant medication, according to product-specific label.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Exenatide 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.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2006-09 with completion listed for 2007-05.

It ran at 14 sites in Japan (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 (time frame: Baseline, Week 12).

It also tracked 4 secondary outcomes, for example Changes in fasting blood glucose from Visits 3 to 7, Change in Serum lipids from Baseline to Week 12 and Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 153 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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