A Study for Patients With Type 1 Diabetes Mellitus

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447213

Enrollment

Registered

2007-03-14

Start date

2007-04-30

Completion date

2008-05-31

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGInsulin glargine

Patient specific, injected, daily, 24 weeks

DRUGHuman Insulin Inhalation Powder

patient specific dose, inhaled, before meals,12 weeks

DRUGInjectable Insulin

Patient specific dose,injected, before meals, 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	12 and 24 weeks

Secondary

Measure	Time frame
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
Proportion of patients who achieve an HbA1c < 7% and <= 6.5%	12 and 24 weeks
Patient-reported treatment satisfaction and insulin delivery satisfaction	12 and 24 weeks
Preference for the study therapies	week 24
Inhaler reliability	throughout the study

Countries

Japan, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026