A Study for Patients With Type 1 Diabetes Mellitus

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin Glargine.

The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.

It had two arms (groups): 1 (experimental) and 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

70 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: Type 1 diabetes mellitus for at least 24 months. Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months. Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study. Satisfactory lung function results to meet the requirement of the study.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: previously received any form of inhaled insulin; have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease; history or presence of liver disease.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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

It started in 2007-04 with completion listed for 2008-05.

It ran at 5 sites in Taiwan (3) and Japan (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c from baseline (time frame: 12 and 24 weeks).

It also tracked 7 secondary outcomes, for example 8-point self monitoring blood glucose profiles, Two hour glucose excursions for the morning, midday, and evening meals, Inhaler reliability, Patient-reported treatment satisfaction and insulin delivery satisfaction and Preference for the study therapies.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Glargine in 70 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.