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Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Human Insulin Inhalation Powder

Injectable Insulin

Insulin Glargine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 1 diabetes Non smoker Normal lung function Exclusion Criteria: Significant pulmonary, hepatic, or renal disease Severe congestive heart failure Active malignancy Systemic glucocorticoid therapy

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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 hrs, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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 hrs, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.

Secondary Outcome Measures

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO).

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion.

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %.

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin)

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires.

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization

To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.

To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire.

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles

Full Information

NCT ID

NCT00127634

First Posted

August 4, 2005

Last Updated

March 7, 2018

Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00127634

Brief Title

Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

Official Title

A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

4. Oversight

5. Study Description

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 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

385 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Human Insulin Inhalation Powder

Other Intervention Name(s)

LY041001

Intervention Description

patient specific dose, inhaled, before meals, 24 months, up to 36 months

Intervention Type

Drug

Intervention Name(s)

Injectable Insulin

Intervention Description

patient specific dose, injectable, before meals, 24 months, up to 36 months.

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Intervention Description

patient specific dose, injectable, as needed, 24 months up to 36 months

Primary Outcome Measure Information:

Title

To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Time Frame

24 months

Title

Time Frame

24 months

Title

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest

Time Frame

24 months

Title

Time Frame

24 months

Title

Time Frame

24 months

Title

Time Frame

24 months

Title

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires.

Time Frame

24 months

Title

To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization

Time Frame

24 months

Title

To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.

Time Frame

throughout the study

Title

To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire.

Time Frame

months 32, 38, 40 and ED visits

Title

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Sacramento

State/Province

California

Country

United States

Facility Name

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

Country

United States

Facility Name

City

Denver

State/Province

Colorado

Country

United States

Facility Name

City

Newark

State/Province

Delaware

Country

United States

Facility Name

City

Hollywood

State/Province

Florida

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

City

Largo

State/Province

Florida

Country

United States

Facility Name

City

New Port Richey

State/Province

Florida

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

City

North Plainfield

State/Province

New Jersey

ZIP/Postal Code

07060

Country

United States

Facility Name

City

Flushing

State/Province

New York

ZIP/Postal Code

11365

Country

United States

Facility Name

City

Lake Success

State/Province

New York

Country

United States

Facility Name

City

New Hyde Park

State/Province

New York

Country

United States

Facility Name

City

Staten Island

State/Province

New York

Country

United States

Facility Name

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

City

Medford

State/Province

Oregon

Country

United States

Facility Name

City

Downingtown

State/Province

Pennsylvania

Country

United States

Facility Name

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

34652

Country

United States

Facility Name

City

Sioux Falls

State/Province

South Dakota

Country

United States

Facility Name

City

Dallas

State/Province

Texas

Country

United States

Facility Name

City

Houston

State/Province

Texas

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

Facility Name

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

City

Aalst

Country

Belgium

Facility Name

City

Arlon

Country

Belgium

Facility Name

City

Brussels

Country

Belgium

Facility Name

City

Edegem

Country

Belgium

Facility Name

City

Leuven

Country

Belgium

Facility Name

City

Liege

Country

Belgium

Facility Name

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

City

Corunna

State/Province

Ontario

Country

Canada

Facility Name

City

Niagara Falls

State/Province

Ontario

Country

Canada

Facility Name

City

Peterborough

State/Province

Ontario

Country

Canada

Facility Name

City

Sarnia

State/Province

Ontario

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

City

Zagreb

Country

Croatia

Facility Name

City

Budapest

Country

Hungary

Facility Name

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 hrs, EST), or speak with your personal physician.

City

Debrecen

Country

Hungary

Facility Name

City

Eger

Country

Hungary

Facility Name

City

Gyula

Country

Hungary

Facility Name

City

Kecskemet

Country

Hungary

Facility Name

City

Nyiregyhaza

Country

Hungary

Facility Name

City

Szeged

Country

Hungary

Facility Name

City

Szolnok

Country

Hungary

Facility Name

City

Bangalore

Country

India

Facility Name

City

Kochin

Country

India

Facility Name

City

Mumbai

Country

India

Facility Name

City

New Dehli

Country

India

Facility Name

City

Noida

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

19772449

Citation

Garg SK, Mathieu C, Rais N, Gao H, Tobian JA, Gates JR, Ferguson JA, Webb DM, Berclaz PY. Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S5-S16. doi: 10.1089/dia.2009.0040.

Results Reference

derived

Links:

URL

https://www.lilly.com/clinical-study-report-csr-synopses

Description

Lilly CSR synopsis

Learn more about this trial

Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

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