A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Eli Lilly and Company1 site in 1 country70 target enrollmentApril 2007

ConditionsDiabetes Mellitus, Type 1

InterventionsInsulin glargine Human Insulin Inhalation Powder Injectable Insulin

DrugsInsulin glargine Human Insulin Inhalation Powder Injectable Insulin

Overview

Phase: Phase 2
Intervention: Insulin glargine
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Enrollment: 70
Locations: 1
Primary Endpoint: Change in HbA1c from baseline
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

May 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•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
•HbA1c equal or less than 11 %
•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

Exclusion Criteria

•Previously received any form of inhaled insulin
•Require a daily total insulin dosage greater than 100 U
•Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
•History or presence of liver disease
•History or presence of kidney disease

Arms & Interventions

1

Intervention: Insulin glargine

1

Intervention: Human Insulin Inhalation Powder

1

Intervention: Injectable Insulin

2

Intervention: Insulin glargine

2

Intervention: Human Insulin Inhalation Powder

2

Intervention: Injectable Insulin

Outcomes

Primary Outcomes

Change in HbA1c from baseline

Time Frame: 12 and 24 weeks

Secondary Outcomes

Proportion of patients who achieve an HbA1c < 7% and <= 6.5%(12 and 24 weeks)
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses(at each visit)
8-point self monitoring blood glucose profiles(12 and 24 weeks)
Two hour glucose excursions for the morning, midday, and evening meals(12 and 24 weeks)
Inhaler reliability(throughout the study)
Patient-reported treatment satisfaction and insulin delivery satisfaction(12 and 24 weeks)
Preference for the study therapies(week 24)