JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): Metformin followed by gliclazide and protaphane (active comparator) and Janumet followed by Lantus insulin injection (active comparator).

The registry classes the interventions as drug.

More on the Plan

T2DM is the leading cause of adult-onset blindness, renal failure, limbs amputation, ischaemic heart disease and stroke in the industrialized world.

Progressive pancreatic beta-cell failure together with insulin resistance underlie the pathogenesis of T2DM.

Glycaemic control is essential and fundamental to the management of diabetes.

Long term follow up of The Diabetes Control and Complications Trial Research Group (DCCT) and U.K.

Who Took Part

71 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Adult patients aged 18 to 80 years old at Visit 1. Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent. Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during study and follow-up period.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: patient has a history of type 1 diabetes mellitus or a history of ketoacidosis; any history of cardiovascular disease, stroke or peripheral vascular disease; any symptoms of ischaemic heart disease like angina.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2011-05 with completion listed for 2014-07.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 71 people.

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

More context: the Insulin Glargine compound page, all human trials.