Diabetes Mellitus, Type 1Phase 3NCT00127634

Study of Human Insulin Inhalation Powder in 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 61 sites in 6 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

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. 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: 385 participants
Where: 61 sitesin 6 countries
Study dates: Jul 2005to 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
Non smoker
Normal lung function

Who cannot join

Significant pulmonary, hepatic, or renal disease
Severe congestive heart failure
Active malignancy
Systemic glucocorticoid therapy

Trial locations and contacts

61 sites in 6 countries.

Country

City, postcode or hospital

61 sites in 6 countries

United States35 sites

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.
Atlanta, Georgia
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Aurora, Colorado
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Baltimore, Maryland
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Chicago, Illinois
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Dallas, Texas
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Denver, Colorado
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Downingtown, Pennsylvania
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Flushing, New York, 11365
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Hollywood, Florida
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Houston, Texas
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Jacksonville, Florida, 32204
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Lake Success, New York
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Largo, Florida
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Louisville, Kentucky
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Medford, Oregon
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Milwaukee, Wisconsin, 53209
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Morehead City, North Carolina, 28557
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New Hyde Park, New York
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New Port Richey, Florida
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Newark, Delaware
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North Plainfield, New Jersey, 07060
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Omaha, Nebraska
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Raleigh, North Carolina
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Renton, Washington, 98055
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Sacramento, California
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San Antonio, Texas
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Sellersville, Pennsylvania, 34652
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Sioux Falls, South Dakota
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Springfield, Illinois
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St Louis, Missouri
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Staten Island, New York
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Walnut Creek, California
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West Palm Beach, Florida

Other trials in United States

Hungary8 sites

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Budapest
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Debrecen
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Eger
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Gyula
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Kecskemét
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Nyíregyháza
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Szeged
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Szolnok

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Belgium6 sites

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Aalst
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Arlon
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Brussels
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Edegem
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Leuven
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Liège

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Canada6 sites

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Corunna, Ontario
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Montreal, Quebec
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Niagara Falls, Ontario
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Peterborough, Ontario
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Sarnia, Ontario
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Winnipeg, Manitoba

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India5 sites

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Bangalore
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Kochi
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Mumbai
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New Dehli
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Noida

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Croatia1 site

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Zagreb

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About this study

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

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, 24 months, up to 36 months
Injectable InsulinDrug
patient specific dose, injectable, before meals, 24 months, up to 36 months.
Insulin GlargineDrug
patient specific dose, injectable, as needed, 24 months up to 36 months

Study groups in NCT00127634
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 assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
Measured: 24 months

Secondary outcomes (11)

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).
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
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 %.
Measured: 24 months
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)
Measured: 24 months
To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires.
Measured: 24 months
To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization
Measured: 24 months
To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Measured: throughout the study
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.
Measured: months 32, 38, 40 and ED visits
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
Measured: 24 months

Timeline

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

Jul 2005May 2008

First posted8 Aug 2005 (estimated)
Study startJul 2005
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: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00127634
Sponsor's protocol ID: 6120
Other IDs: H7U-MC-IDAH
Status last verified: Mar 2018
First submitted: 4 Aug 2005
Last updated: 9 Mar 2018
Results posted: No

Publications

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.
PubMed 19772449

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?

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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 Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00127634
Acronym / sponsor ID: 6120
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Jul 2005
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 8 Aug 2005 (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.

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 (3 listed)

Type 1 diabetes
Non smoker
Normal lung function

Key exclusion criteria (4 listed)

Significant pulmonary, hepatic, or renal disease
Severe congestive heart failure
Active malignancy
Systemic glucocorticoid therapy

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, 24 months, up to 36 months	Drug	1
Injectable Insulinpatient specific dose, injectable, before meals, 24 months, up to 36 months.	Drug	2
Insulin Glarginepatient specific dose, injectable, as needed, 24 months up to 36 months	Drug	1, 2

Primary outcome

To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
Time frame: 24 months

11 secondary outcomes

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).
Time frame: 24 months
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
Time frame: 24 months
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
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.
Time frame: 24 months
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 %.
Time frame: 24 months
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)
Time frame: 24 months
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
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
To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Time frame: throughout the study
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
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
Time frame: 24 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 19772449Garg 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.

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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

61 sites in 6 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 61 sites in 6 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 3 inclusion and 4 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 61 sites in United States, Hungary, Belgium, Canada, India and 1 more country. 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 assess change in baseline to endpoint in HbA1c in type 1 diabetic patients. (time frame: 24 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 NCT00127634, 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.