Diabetes Mellitus, Type 1Phase 3NCT00356109

Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A Phase 3 study testing Human Insulin Inhalation Powder, Injectable insulin and Insulin Glargine in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 37 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Human Insulin Inhalation Powder, Injectable insulin and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 494 participants
Where: 37 sitesin 9 countries
Study dates: Aug 2006to May 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

37 sites in 9 countries.

Country

City, postcode or hospital

37 sites in 9 countries

United States14 sites

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.
Atlanta, Georgia, 30309
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Aurora, Colorado, 80045
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Baltimore, Maryland, 21204
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Dallas, Texas, 75246
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El Paso, Texas, 79935
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Grand Rapids, Michigan, 49503
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Idaho Falls, Idaho, 83404
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Indianapolis, Indiana, 46250
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Miami, Florida, 33136
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New York, New York, 10025
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Ogden, Utah, 84403
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Philadelphia, Pennsylvania, 19104
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San Antonio, Texas, 78229
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Springfield, Illinois, 62704

Other trials in United States

Belgium5 sites

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Aalst, 9300
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Brussels, 1070
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Edegem, 2650
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Ghent, 9000
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Leuven, 3000

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France5 sites

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.
Angers, 49033
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Paris, 75475
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Poitiers, 86000
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Toulouse, 31054
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Tours, 37044

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India5 sites

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Bangalore, 560 054
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Chennai, 600 013
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Kochi, 682026
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Mumbai, 400 007
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New Delhi, 110 029

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Germany2 sites

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Aschaffenburg, 63739
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Münster, 48145

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Italy2 sites

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.
Milan, 20142
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Perugia, 06100

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Mexico2 sites

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Guadalajara, 44340
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Mexico City, 06726

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Argentina1 site

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.
Buenos Aires, C1213AAH

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Puerto Rico1 site

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.
Toa Baja, 00950

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About this study

Official title: 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

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.

Conditions: Diabetes Mellitus, Type 1
Being tested: Human Insulin Inhalation Powder, Injectable insulin, Insulin Glargine
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Insulin Inhalation PowderDrug
Also called LY041001
patient specific dose, inhaled, before meals, 6 months
Injectable insulinDrug
patient specific dose, injected, before meals, 6 months
Insulin GlargineDrug
patient specific dose, injectable, before meals, 6 months

Study groups in NCT00356109
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine
2	Active comparator	Not described Receives: Drug: Injectable insulin; Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006May 2008

First posted25 Jul 2006 (estimated)
Study startAug 2006
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00356109
Sponsor's protocol ID: 9627
Other IDs: H7U-MC-IDAV
Status last verified: Mar 2018
First submitted: 21 Jul 2006
Last updated: 9 Mar 2018
Results posted: No

Publications

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.
PubMed 19772445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00356109
Acronym / sponsor ID: 9627
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 494 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Aug 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 25 Jul 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Human Insulin Inhalation Powder, Drug: Insulin Glargine
2	Active comparator	Drug: Injectable insulin, Drug: Insulin Glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human Insulin Inhalation PowderAlso: LY041001patient specific dose, inhaled, before meals, 6 months	Drug	1
Injectable insulinpatient specific dose, injected, before meals, 6 months	Drug	2
Insulin Glarginepatient specific dose, injectable, before meals, 6 months	Drug	1, 2

Primary outcome

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.
Time frame: 6 months

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Derived from this study: PubMed 19772445Comulada 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.

Related trials for Diabetes Mellitus, Type 1

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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

37 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Insulin Inhalation Powder, Injectable insulin and Insulin Glargine in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 37 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Belgium, France, India, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356109, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.