NCT00356109|CompletedPhase 3

Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

9627H7U-MC-IDAV

Study Type

interventional

Target

494

Locations

9 countries

Sites

Timeline

RegisteredJul 2006

StartedAug 2006

CompletionMay 2008

Brief Summary

A study to test for non-inferiority of preprandial HIIP \[also known as AIR® Inhaled Insulin Powder\]\[AIR® is a registered trademark of Alkermes,Inc.\] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus. This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes. The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

494

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Aug 2006

Geographic Reach

9 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

July 21, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed

7 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed

Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

July 21, 2006

Last Update Submit

March 7, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
6 months

Secondary Outcomes (4)

Insulin dose requirements
throughout the study
Insulin antibody binding levels
baseline, 1 month, 6 months, follow-up
To compare HbAlc change
6 months
To assess rate and incidence of hypoglycemia
6 months

Study Arms (2)

1

EXPERIMENTAL

Drug: Human Insulin Inhalation PowderDrug: Insulin Glargine

2

ACTIVE COMPARATOR

Drug: Injectable insulinDrug: Insulin Glargine

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 6 months

Also known as: LY041001

Injectable insulinDRUG

patient specific dose, injected, before meals, 6 months

Insulin GlargineDRUG

patient specific dose, injectable, before meals, 6 months

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes for at least 24 months
Have an HbA1c less than or equal to 11%
Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
Non-smoker

You may not qualify if:

Require a daily total insulin dosage greater than 150 U at screening
Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
Systemic glucocorticoid therapy
Clinical signs or symptoms of liver disease, acute or chronic hepatitis
History of lung transplantation and/or lung cancer
Diagnosed with pneumonia in the 3 months prior to screening
History of renal transplantation
Active or untreated malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Alkermes, Inc.collaborator

Study Sites (37)

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.

Aurora, Colorado, 80045, United States

Location

Miami, Florida, 33136, United States

Location

Atlanta, Georgia, 30309, United States

Location

Idaho Falls, Idaho, 83404, United States

Location

Springfield, Illinois, 62704, United States

Location

Indianapolis, Indiana, 46250, United States

Location

Baltimore, Maryland, 21204, United States

Location

Grand Rapids, Michigan, 49503, United States

Location

New York, New York, 10025, United States

Location

Philadelphia, Pennsylvania, 19104, United States

Location

Dallas, Texas, 75246, United States

Location

El Paso, Texas, 79935, United States

Location

San Antonio, Texas, 78229, United States

Location

Ogden, Utah, 84403, United States

Location

Buenos Aires, C1213AAH, Argentina

Location

Aalst, 9300, Belgium

Location

Brussels, 1070, Belgium

Location

Edegem, 2650, Belgium

Location

Ghent, 9000, Belgium

Location

Leuven, 3000, Belgium

Location

Angers, 49033, France

Location

Paris, 75475, France

Location

Poitiers, 86000, France

Location

Toulouse, 31054, France

Location

Tours, 37044, France

Location

Aschaffenburg, 63739, Germany

Location

Münster, 48145, Germany

Location

Bangalore, 560 054, India

Location

Chennai, 600 013, India

Location

Kochi, 682026, India

Location

Mumbai, 400 007, India

Location

New Delhi, 110 029, India

Location

Milan, 20142, Italy

Location

Perugia, 06100, Italy

Location

Guadalajara, 44340, Mexico

Location

Mexico City, 06726, Mexico

Location

Toa Baja, 00950, Puerto Rico

Location

Related Publications (1)

Comulada AL, Renard E, Nakano M, Rais N, Mao X, Webb DM, Milicevic Z. Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S17-25. doi: 10.1089/dia.2009.0041.
PMID: 19772445DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 25, 2006

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

DE(2)FR(5)IT(2)US(14)AR(1)IN(5)BE(5)ME(2)PR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (37)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations