Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Phase 3

Completed

• Conditions: Diabetes Mellitus; Asthma; Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Human Insulin Inhalation Powder; Drug: injected insulin

• Registration Number: NCT00157339
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• 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: 2019-09-09
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Type 1 or type 2 diabetes
• asthma or COPD

Exclusion Criteria

• Current smoking habit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.	12 months

Secondary Outcome Measures

Name	Time	Method
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays.	12 months
To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months.	12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin)	12 months
To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.	throughout the study

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.; 🇹🇭 Bangkok, Thailand