Diabetes Mellitus, Type 2Phase 3NCT00325364

Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

A Phase 3 study testing Human Insulin Inhalation Powder and Injectable insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 43 sites in 11 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 2 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 2
What is being tested?: Human Insulin Inhalation Powder and Injectable insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 415 participants
Where: 43 sitesin 11 countries
Study dates: Apr 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 2 diabetes
Non smoker
Normal lung function

Who cannot join

Pulmonary, hepatic, or renal disease
Congestive heart failure
Active malignancy
Systemic glucocorticoid therapy

Trial locations and contacts

43 sites in 11 countries.

Country

City, postcode or hospital

43 sites in 11 countries

United States9 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.
Baton Rouge, Louisiana, 70808
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Charleston, West Virginia, 25304
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Greenville, South Carolina, 29605
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Hamilton, New Jersey, 08610
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Jacksonville, Florida, 32204
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Miami, Florida, 33156
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Ogden, Utah, 84403
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Sacramento, California, 95825
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Santa Ana, California, 92705

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Germany6 sites

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Berlin, 10115
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Dresden, 01307
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Erlangen, 91054
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Frankfurt, 60596
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Leipzig, D-04103
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Mainz, D-55116

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Italy5 sites

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Catania, 95100
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Genova, 16132
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Milan, 20132
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Pisa, 56100
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Rome, 00168

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Hungary4 sites

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Budapest, H-1139
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Makó, 6900
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Veszprém, 8200
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Zalaegerszeg, 8900

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Brazil3 sites

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Fortaleza, 60120-020
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Porto Alegre, 90035-003
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São Paulo, 04020041

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India3 sites

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Bangalore, 560010
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Mumbai, 400 007
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Pune, 411005

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Poland3 sites

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Katowice, 40-044
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Lublin, 20-954
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Oleśnica

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Puerto Rico3 sites

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Manati, 00674
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San Juan, 00907
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Yabucoa, 00767

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Taiwan3 sites

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Changhua, 500
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Neihu Taipei, 114
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Yungkang City, 710

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Mexico2 sites

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Mexico City, 06700
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Monterrey, 64410

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Portugal2 sites

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Coimbra, 3000-076
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Lisbon, 1250-203

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About this study

Official title: A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Conditions: Diabetes Mellitus, Type 2
Being tested: Human Insulin Inhalation Powder, Injectable insulin
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, 24 months
Injectable insulinDrug
patient specific dose, injectable, before meals, 24 months

Study groups in NCT00325364
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Human Insulin Inhalation Powder
2	Active comparator	Not described Receives: Drug: Injectable insulin

What is being measured

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

To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Measured: 6 months

Secondary outcomes (9)

To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Measured: 24 months
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Measured: baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Measured: baseline, 6 months, 12 months, 18 months, 24 months
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Measured: baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
Measured: throughout the study
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Measured: 24 months
To test dose titration methods
Measured: 6 months
To assess inhaler reliability
Measured: throughout the study
To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Measured: 3 months, 6 months

Timeline

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

Apr 2006May 2008

First posted12 May 2006 (estimated)
Study startApr 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 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: 415 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00325364
Sponsor's protocol ID: 9626
Other IDs: H7U-MC-IDAU
Status last verified: Sep 2019
First submitted: 10 May 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

Gross JL, Nakano M, Colon-Vega G, Ortiz-Carasquillo R, Ferguson JA, Althouse S, Tobian JA, Berclaz PY, Milicevic Z. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S27-34. doi: 10.1089/dia.2009.0037.
PubMed 19772446

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 2 trials

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, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
ClinicalTrials.gov ID: NCT00325364
Acronym / sponsor ID: 9626
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 415 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Apr 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 12 May 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: 2

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

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 2 diabetes
Non smoker
Normal lung function

Key exclusion criteria (4 listed)

Pulmonary, hepatic, or renal disease
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	Drug	1
Injectable insulinpatient specific dose, injectable, before meals, 24 months	Drug	2

Primary outcome

To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Time frame: 6 months

9 secondary outcomes

To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Time frame: 24 months
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Time frame: baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Time frame: baseline, 6 months, 12 months, 18 months, 24 months
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Time frame: baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
Time frame: throughout the study
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Time frame: 24 months
To test dose titration methods
Time frame: 6 months
To assess inhaler reliability
Time frame: throughout the study
To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Time frame: 3 months, 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 16 Sep 2019.
Results publication: PubMed 19772446Gross JL, Nakano M, Colon-Vega G, Ortiz-Carasquillo R, Ferguson JA, Althouse S, Tobian JA, Berclaz PY, Milicevic Z. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S27-34. doi: 10.1089/dia.2009.0037.
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, Type 2

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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

43 sites in 11 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 Injectable insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 43 sites in 11 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 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 43 sites in United States, Germany, Italy, Hungary, Brazil and 6 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 assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin (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 NCT00325364, 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.