Diabetes MellitusPhase 3NCT00157339

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

A Phase 3 study testing Human Insulin Inhalation Powder and injected insulin in people with Diabetes Mellitus and Asthma, run by Eli Lilly and Company at 101 sites in 16 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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive
What is being tested?: Human Insulin Inhalation Powder and injected insulin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 101 sitesin 16 countries
Study dates: Aug 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 or type 2 diabetes
asthma or COPD

Who cannot join

Current smoking habit

Trial locations and contacts

101 sites in 16 countries.

Country

City, postcode or hospital

101 sites in 16 countries

United States36 sites

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Baltimore, Maryland, 21204
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Belvidere, Illinois, 61008
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Brockton, Massachusetts, 02301
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Burbank, California, 91505
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Charlotte, North Carolina, 28204
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Chicago, Illinois, 60631
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Clearwater, Florida, 33756
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Downingtown, Pennsylvania, 19335
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El Paso, Texas, 79902
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Greenbrae, California, 94904
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Hollywood, Florida, 33021
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Houston, Texas, 77090
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Humble, Texas, 77338
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Jacksonville, Florida, 32204
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Kettering, Ohio, 45429
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Las Vegas, Nevada, 89146
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Levittown, Pennsylvania, 19056
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Louisville, Kentucky, 40213
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Medford, Oregon, 97504
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Midland, Texas, 79705
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Montgomery, Alabama, 36106
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Morehead City, North Carolina, 28557
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New Port Richey, Florida, 34652
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Norfolk, Virginia, 23502
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Norwich, Connecticut, 06360
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Ocala, Florida, 34471
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Omaha, Nebraska, 68131
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San Antonio, Texas, 78229
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Sellersville, Pennsylvania, 18960
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Simpsonville, South Carolina, 29681
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Sioux Falls, South Dakota, 57105
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Spartanburg, South Carolina, 29303
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Springfield, Illinois, 62704
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Tacoma, Washington, 98405
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Topeka, Kansas, 66606
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West Palm Beach, Florida, 33401

Other trials in United States

India20 sites

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Ahmedabad, 38009
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Bangalore, 560017
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Chennai, 600010
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Coimbatore, 643209
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Gandhinagar, 382428
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Hyderabaad, 500033
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Kochi, 682026
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Kolkata, 700054
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Kormangala, 560034
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Mangalore, 575001
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Mumbai, 400016
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Nagpur, 440012
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New Delhi, 110057
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Noida, 201301
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P.O Ernakulam, 682304
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Porur, 600116
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Pune, 411011
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Secunderabad, 800003
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Tamil Nadu, 600 006
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Vellore, 632 004

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Hungary8 sites

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Budapest, 1076
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Eger, 3300
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Gyula, 5701
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Kalocsa, 6300
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Kecskemét, 6000
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Nyíregyháza, H-4400
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Székesfehérvár, 8000
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Szolnok, 5000

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Philippines8 sites

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Barangay Pembo, 1218
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Dillman
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Ermita
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España
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Manila, 1007
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Pasig
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Quezon City, 1102
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San Juan City

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Canada7 sites

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Corunna, Ontario, N0N 1G0
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Longueuil, Quebec, J4N 1E1
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Niagara Falls, Ontario, L2G1J4
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Sainte-Foy, Quebec, G1V 4G2
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Sarnia, Ontario, N7T 4X3
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St. John's, Newfoundland and Labrador, A1B 3V6
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Winnipeg, Manitoba, R3E 3P4

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Bulgaria6 sites

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Haskovo, 6300
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Pazardzhik, 4400
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Pleven, 5800
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Plovdiv, 4003
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Sofia, 1606
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Stara Zagora, 6003

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Argentina4 sites

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Buenos Aires, C1181ACH
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Córdoba, 5000
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Mendoza, 5500
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Ramos Mejía, B1704ETD

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Chile2 sites

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San Miguel, S/N
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Viña del Mar, 2570017

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Mexico2 sites

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Mexico City, 11650
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Monterrey, 64460

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Thailand2 sites

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Bangkok, 10330
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Bangkoknoi, 10700

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Colombia1 site

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Bogotá

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Croatia1 site

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Zagreb, HR-10000

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Hong Kong1 site

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Kwun Tong

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Puerto Rico1 site

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Ponce, 00732

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Singapore1 site

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Singapore, 159964

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Taiwan1 site

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Taichung, 407

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About this study

Official title: A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

Conditions: Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive
Being tested: Human Insulin Inhalation Powder, injected insulin
Medical subject headings: Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive

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

Study groups in NCT00157339
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Human Insulin Inhalation Powder
2	Active comparator	Not described Receives: Drug: injected insulin

What is being measured

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

To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
Measured: 12 months

Secondary outcomes (16)

To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin)
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status.
Measured: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization.
Measured: 12 months
To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Measured: throughout the study
To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients.
Measured: 12 months

Timeline

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

Aug 2005May 2008

First posted12 Sep 2005 (estimated)
Study startAug 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 MellitusStudies 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: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00157339
Sponsor's protocol ID: 7091
Other IDs: H7U-MC-IDAS
Status last verified: Sep 2019
First submitted: 7 Sep 2005
Last updated: 17 Sep 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

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.
PubMed 19772447

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma
ClinicalTrials.gov ID: NCT00157339
Acronym / sponsor ID: 7091
Conditions: Diabetes Mellitus, Asthma, Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Aug 2005
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 12 Sep 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
2	Active comparator	Drug: injected insulin

Who may qualify

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

Key inclusion criteria (2 listed)

Type 1 or type 2 diabetes
asthma or COPD

Key exclusion criteria (1 listed)

Current smoking habit

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, 12 months	Drug	1
injected insulinpatient specific dose, injected, before meals, 12 months.	Drug	2

Primary outcome

To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
Time frame: 12 months

16 secondary outcomes

To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin)
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status.
Time frame: 12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization.
Time frame: 12 months
To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Time frame: throughout the study
To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients.
Time frame: 12 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 17 Sep 2019.
Results publication: PubMed 19772447Ang 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.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) study director

Eli Lilly and Company

101 sites in 16 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 and injected insulin in people with Diabetes Mellitus and Asthma, run by Eli Lilly and Company at 101 sites in 16 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 2 inclusion and 1 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, India, Hungary, Philippines, Canada and 11 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 the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c. (time frame: 12 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 NCT00157339, 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 17 Sep 2019.