Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

Phase 3

Completed

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

• Registration Number: NCT00356109
• Lead Sponsor: Eli Lilly and Company

Brief Summary

A study to test for non-inferiority of preprandial HIIP \[also known as AIR® Inhaled Insulin Powder\]\[AIR® is a registered trademark of Alkermes,Inc.\] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

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: 2006-07-21
• Study First Submitted QC: 2006-07-21
• Study First Posted: 2006-07-25
• Study Start: 2006-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2018-03
• Disposition First Submitted: 2018-03-07
• Disposition First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Disposition First Posted: 2018-03-09
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

• Type 1 diabetes for at least 24 months
• Have an HbA1c less than or equal to 11%
• Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
• Non-smoker

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Exclusion Criteria

• Require a daily total insulin dosage greater than 150 U at screening
• Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
• Systemic glucocorticoid therapy
• Clinical signs or symptoms of liver disease, acute or chronic hepatitis
• History of lung transplantation and/or lung cancer
• Diagnosed with pneumonia in the 3 months prior to screening
• History of renal transplantation
• Active or untreated malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Human Insulin Inhalation Powder	-
2	Injectable insulin	-
2	Insulin Glargine	-
1	Insulin Glargine	-

Primary Outcome Measures

Name	Time	Method
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.	6 months

Secondary Outcome Measures

Name	Time	Method
Insulin antibody binding levels	baseline, 1 month, 6 months, follow-up
To compare HbAlc change	6 months
Insulin dose requirements	throughout the study
To assess rate and incidence of hypoglycemia	6 months

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.; 🇵🇷 Toa Baja, Puerto Rico