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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 7, 2005

Last Updated Date

July 3, 2008

Start Date ^†

August 2005

Current Primary Outcome Measures ^†

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00157339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 %. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetes Mellitus
Asthma
Pulmonary Disease, Chronic Obstructive

Intervention ^†

Drug: Human Insulin Inhalation Powder
Drug: injected insulin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

299

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Type 1 or type 2 diabetes
asthma or COPD

Exclusion Criteria:

Current smoking habit

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Bulgaria, Canada, Chile, Colombia, Croatia, Hong Kong, Hungary, India, Mexico, Philippines, Puerto Rico, Singapore, Taiwan, Thailand

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00157339

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

H7U-MC-IDAS

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Alkermes

Investigators ^†

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hour, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.