A Study for Patients With Type 1 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin glargine; Drug: Human Insulin Inhalation Powder; Drug: Injectable Insulin

• Registration Number: NCT00447213
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-14
• Study Start: 2007-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Insulin glargine	-
1	Human Insulin Inhalation Powder	-
2	Human Insulin Inhalation Powder	-
1	Injectable Insulin	-
2	Injectable Insulin	-
2	Insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇨🇳 Tao-Yuan, Taiwan