Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Injectable insulin; Drug: Human Insulin Inhalation Powder

• Registration Number: NCT00325364
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Disposition First Submitted: 2018-03-07
• Disposition First Submitted QC: 2018-03-07
• Disposition First Posted: 2018-03-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

• Type 2 diabetes
• Non smoker
• Normal lung function

Exclusion Criteria

• Pulmonary, hepatic, or renal disease
• Congestive heart failure
• Active malignancy
• Systemic glucocorticoid therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin	6 months

Secondary Outcome Measures

Name	Time	Method
To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin	24 months
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight	baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction	baseline, 6 months, 12 months, 18 months, 24 months
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c	baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia	throughout the study
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements	24 months
To test dose titration methods	6 months
To assess inhaler reliability	throughout the study
To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients	3 months, 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.; 🇨🇳 Yungkang City, Taiwan