Diabetes Mellitus, Type 2Phase 3NCT00355849

Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

A Phase 3 study testing Human Insulin Inhalation Powder and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 69 sites in 12 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 evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Human Insulin Inhalation Powder and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 555 participants
Where: 69 sitesin 12 countries
Study dates: Aug 2006to Jun 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 2 diabetes mellitus
one or more oral antihyperglycemic medications
once-daily insulin glargine
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
Non-smoker

Who cannot join

taking a TZD dose greater than what is indicated
more than two episodes of severe hypoglycemia during the 6 months prior
Have had a lower respiratory infection in the 3 months prior
systemic glucocorticoid therapy
clinical signs or symptoms of liver disease, acute or chronic hepatitis
history of renal transplantation
Have an active or untreated malignancy
Require more than 150 U/day of insulin glargine

Trial locations and contacts

69 sites in 12 countries.

Country

City, postcode or hospital

69 sites in 12 countries

United States24 sites

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Ann Arbor, Michigan, 48108
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Atlanta, Georgia, 30309
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Austin, Texas, 78731
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Cherry Hill, New Jersey, 08002
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Dallas, Texas, 75230
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Flemington, New Jersey, 08822
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Fresno, California, 93720
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Georgetown, Texas, 78626
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Grand Rapids, Michigan, 49503
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Metairie, Louisiana, 70006
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Midvale, Utah, 84047
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Nashua, New Hampshire, 03063
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New Albany, Indiana, 47150
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New Braunfels, Texas, 78130
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Ogden, Utah, 84403
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Olympia, Washington, 98506
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Omaha, Nebraska, 68131
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Peoria, Illinois, 61615
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Philadelphia, Pennsylvania, 19104
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Pomona, California, 91767
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78229
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Topeka, Kansas, 66606
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West Palm Beach, Florida, 33401

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Germany8 sites

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Aschaffenburg, 63739
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Berlin, 10115
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Dresden, 01307
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Hamburg, 22607
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Mainz, D-55116
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Münster, 48145
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Rodgau, D-63110
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Witten, 58455

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Spain7 sites

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A Coruña, 15006
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Alicante, 03114
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Alzira, 46220
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Barcelona, 08017
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Dos Hermanas, 41014
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Madrid, 28006
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Palma de Mallorca, 07198

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United Kingdom7 sites

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Birmingham, West Midlands, B9 5SS
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Blackburn, East Lancashire, BB2 3HH
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Livingston, West Lothian, EH54 6PP
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Manchester, M41 5SL
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Middlesbrough, Cleveland, TS4 3BW
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Penarth, South Glamorgan, CF64 2XX
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Swansea, Wales, SA6 6NL

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Canada5 sites

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Cambridge, Ontario, N2R 7L6
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Red Deer, Alberta, T4N 6V7
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Saint John, New Brunswick, E2L 4L2
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Sainte-Foy, Quebec, G1V 4G2
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Thornhill, Ontario, L4J 8L7

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India4 sites

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Bangalore, 560038
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Chennai, 600 010
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Indore, 452 003
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Ludhiana, 141001

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Puerto Rico4 sites

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Carolina, 00983
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Manati, 00674
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San Juan, 00907
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Toa Baja, 00950

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Israel3 sites

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Holon, 22100
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Nahariya, 22100
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Tel HaShomer, 52621

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Brazil2 sites

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Curitiba, 80060-900
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São Paulo, 04020041

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Russia2 sites

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Moscow, 125315
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Saint Petersburg, 195176

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South Korea2 sites

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Seoul, 137-701
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Suwon, 442-721

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South Africa1 site

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Pretoria, 0083

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About this study

Official title: A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

Conditions: Diabetes Mellitus, Type 2
Being tested: Human Insulin Inhalation Powder, Insulin Glargine
Medical subject headings: Diabetes Mellitus, Type 2

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, 52 weeks
Insulin GlargineDrug
patient specific dose, injectable, before meals, 52 weeks

Study groups in NCT00355849
Study group	Role	What they receive
1	Experimental	Intensified Glargine Receives: Drug: Insulin Glargine
2	Experimental	HIIP Receives: Drug: Human Insulin Inhalation Powder
3	Experimental	Intensified Glargine plus HIIP Receives: Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine

What is being measured

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

To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.
Measured: 24 weeks

Secondary outcomes (3)

To measure changes in HbA1c over time
Measured: 24 weeks
To assess insulin dose requirements
Measured: 24 and 52 weeks
To assess rate and incidence of hypoglycemia
Measured: 24 and 52 weeks

Timeline

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

Aug 2006Jun 2008

First posted25 Jul 2006 (estimated)
Study startAug 2006
Primary completionJun 2008
Study completionJun 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 2Studies 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: 555 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355849
Sponsor's protocol ID: 9632
Other IDs: H7U-MC-IDBA
Status last verified: Sep 2019
First submitted: 21 Jul 2006
Last updated: 16 Sep 2019
Results posted: 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

Rosenstock J, Eliaschewitz FG, Heilmann CR, Muchmore DB, Hayes RP, Belin RM. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S63-73. doi: 10.1089/dia.2009.0059.
PubMed 19772451

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 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine
ClinicalTrials.gov ID: NCT00355849
Acronym / sponsor ID: 9632
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 555 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Aug 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Insulin GlargineIntensified Glargine
2	Experimental	Drug: Human Insulin Inhalation PowderHIIP
3	Experimental	Drug: Human Insulin Inhalation Powder, Drug: Insulin GlargineIntensified Glargine plus HIIP

Who may qualify

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

Key inclusion criteria (5 listed)

type 2 diabetes mellitus
one or more oral antihyperglycemic medications
once-daily insulin glargine
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
Non-smoker

Key exclusion criteria (8 listed)

taking a TZD dose greater than what is indicated
more than two episodes of severe hypoglycemia during the 6 months prior
Have had a lower respiratory infection in the 3 months prior
systemic glucocorticoid therapy
clinical signs or symptoms of liver disease, acute or chronic hepatitis

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, 52 weeks	Drug	2, 3
Insulin Glarginepatient specific dose, injectable, before meals, 52 weeks	Drug	1, 3

Primary outcome

To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.
Time frame: 24 weeks

3 secondary outcomes

To measure changes in HbA1c over time
Time frame: 24 weeks
To assess insulin dose requirements
Time frame: 24 and 52 weeks
To assess rate and incidence of hypoglycemia
Time frame: 24 and 52 weeks

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 16 Sep 2019.
Results publication: PubMed 19772451Rosenstock J, Eliaschewitz FG, Heilmann CR, Muchmore DB, Hayes RP, Belin RM. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S63-73. doi: 10.1089/dia.2009.0059.
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.

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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

69 sites in 12 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 Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 69 sites in 12 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 5 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 16 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 69 sites in United States, Germany, Spain, United Kingdom, Canada and 7 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 compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin. (time frame: 24 weeks). 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 NCT00355849, 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 16 Sep 2019.