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

NCT ID: NCT00157339

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus Asthma Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Human Insulin Inhalation Powder

Intervention Type DRUG

patient specific dose, inhaled, before meals, 12 months

2

Group Type ACTIVE_COMPARATOR

injected insulin

Intervention Type DRUG

patient specific dose, injected, before meals, 12 months.

Interventions

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Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 12 months

Intervention Type DRUG

injected insulin

patient specific dose, injected, before meals, 12 months.

Intervention Type DRUG

Other Intervention Names

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LY041001

Eligibility Criteria

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Inclusion Criteria

* Type 1 or type 2 diabetes
* asthma or COPD

Exclusion Criteria

* Current smoking habit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Montgomery, Alabama, United States

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Barangay Pembo, , Philippines

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Dillman, , Philippines

Site Status

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Ermita, , Philippines

Site Status

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España, , Philippines

Site Status

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Manila, , Philippines

Site Status

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Pasig, , Philippines

Site Status

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Quezon City, , Philippines

Site Status

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San Juan City, , Philippines

Site Status

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Ponce, , Puerto Rico

Site Status

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Singapore, , Singapore

Site Status

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Taichung, , Taiwan

Site Status

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

Site Status

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.

Bangkoknoi, , Thailand

Site Status

Countries

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

References

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Ang E, Lawrence MK, Heilmann CR, Ferguson JA, Tobian JA, Webb DM, Berclaz PY. Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S35-44. doi: 10.1089/dia.2009.0054.

Reference Type RESULT
PMID: 19772447 (View on PubMed)

Other Identifiers

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H7U-MC-IDAS

Identifier Type: OTHER

Identifier Source: secondary_id

7091

Identifier Type: -

Identifier Source: org_study_id

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