Diabetes Mellitus, Type 2Phase 3NCT00330473

A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

A Phase 3 study testing Human Insulin Inhalation Powder and Insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 60 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 compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options. 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
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,019 participants
Where: 60 sitesin 12 countries
Study dates: Jun 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
Insulin-naive
Non-smoker

Who cannot join

Significant pulmonary, hepatic or renal disease
severe congestive heart failure
active malignancy or malignancy within the last 5 years
systemic glucocorticoid therapy

Trial locations and contacts

60 sites in 12 countries.

Country

City, postcode or hospital

60 sites in 12 countries

United States24 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.
Billerica, Massachusetts, 01821
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Butte, Montana, 59701
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Chicago Heights, Illinois, 60411
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Corpus Christi, Texas, 78404
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Corvallis, Oregon, 97330
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Gig Harbor, Washington, 98335
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Houston, Texas, 77005
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Huntington Beach, California, 92646
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Jacksonville, Florida, 32216
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Lafayette, Indiana, 47904
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Medford, Oregon, 97504
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Metairie, Louisiana, 70006
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New Port Richey, Florida, 34652
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New York, New York, 10021
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Olympia, Washington, 98506
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Orlando, Florida, 32806
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Pasadena, Maryland, 21122
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Peoria, Illinois, 61615
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Pomona, California, 91767
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Rockville, Maryland, 20854
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Spokane, Washington, 99202
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Tacoma, Washington, 98405
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Topeka, Kansas, 66606
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Westfield, New York, 14787

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Canada8 sites

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Edmonton, Alberta, T5J 3N4
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Kingston, Ontario, K7L 2V7
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Mississauga, Ontario, L5B 4A2
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Montreal, Quebec, H2W 1T8
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Ottawa, Ontario, K1H 1A2
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St. John's, Newfoundland and Labrador, A1B 3V6
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Windsor, Ontario, N8W 3K2
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Winnipeg, Manitoba, R3E 3P4

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Brazil5 sites

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Belo Horizonte
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Campinas, 13083-990
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Fortaleza, 60430-350
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Rio de Janeiro, 21941-590
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Setor Oeste/Goiania, 74043-110

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Denmark4 sites

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Aarhus, 8000
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Hellerup, 2900
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Hvidovre, 2650
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Koege, 4600

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India4 sites

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Ahmedabad, 380052
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Bangalore, 560004
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Chennai, 600 013
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Pune, 411007

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Poland4 sites

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Katowice, 40-044
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Lublin, 20-538
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Warsaw, 03-242
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Wroclaw, 50-127

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Puerto Rico4 sites

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Bayamón, 00956
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Carolina, 00983
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Rio Piedras, 00921
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San Juan, 00926

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Russia2 sites

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Moscow, 119881
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Saint Petersburg, 193257

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South Africa2 sites

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Cape Town, 7505
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Pretoria, 0143

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Argentina1 site

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Buenos Aires, C1426ABP

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Mexico1 site

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Monterrey, 64700

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South Korea1 site

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Seoul, 138-736

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About this study

Official title: A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options

Conditions: Diabetes Mellitus, Type 2
Being tested: Human Insulin Inhalation Powder, 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, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
InsulinDrug
patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)

Study groups in NCT00330473
Study group	Role	What they receive
1	Experimental	Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder. Receives: Drug: Human Insulin Inhalation Powder
2	Active comparator	Treatment Options available on the market. Receives: Drug: Insulin

What is being measured

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

To assess acceptance of insulin therapy
Measured: 9 months
To assess blood sugar control as measured by HbA1c
Measured: baseline, 1,3,5,7,9 months

Secondary outcomes (5)

To measure changes in HbA1c over time
Measured: baseline, 1,3,5,7,9 months
To assess safety by review of adverse events
Measured: throughout study
To assess patient-reported outcomes based on the W-BQ12 questionnaire
Measured: screening, baseline, months 5, and 9
To assess patient-reported outcomes based on the DSC-R questionnaire
Measured: screening,baseline, months 5 and 9
To assess patient-reported outcomes based on the DTSQ Questionnaire
Measured: Screening,baseline, months 5 and 9

Timeline

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

Jun 2006May 2008

First posted26 May 2006 (estimated)
Study startJun 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: 1,019 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00330473
Sponsor's protocol ID: 9628
Other IDs: H7U-MC-IDAW
Status last verified: Sep 2019
First submitted: 24 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

Bergenstal RM, Freemantle N, Leyk M, Cutler GB Jr, Hayes RP, Muchmore DB. Does availability of AIR insulin increase insulin use and improve glycemic control in patients with type 2 diabetes? Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S45-52. doi: 10.1089/dia.2009.0028.
PubMed 19772448

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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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
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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)

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 Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options
ClinicalTrials.gov ID: NCT00330473
Acronym / sponsor ID: 9628
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,019 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 26 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 PowderTreatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
2	Active comparator	Drug: InsulinTreatment Options available on the market.

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
Insulin-naive
Non-smoker

Key exclusion criteria (4 listed)

Significant pulmonary, hepatic or renal disease
severe congestive heart failure
active malignancy or malignancy within the last 5 years
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, 9 months ( if patient chooses Human Insulin Inhalation Powder option)	Drug	1
Insulinpatient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)	Drug	2

Primary outcome

To assess acceptance of insulin therapy
Time frame: 9 months
To assess blood sugar control as measured by HbA1c
Time frame: baseline, 1,3,5,7,9 months

5 secondary outcomes

To measure changes in HbA1c over time
Time frame: baseline, 1,3,5,7,9 months
To assess safety by review of adverse events
Time frame: throughout study
To assess patient-reported outcomes based on the W-BQ12 questionnaire
Time frame: screening, baseline, months 5, and 9
To assess patient-reported outcomes based on the DSC-R questionnaire
Time frame: screening,baseline, months 5 and 9
To assess patient-reported outcomes based on the DTSQ Questionnaire
Time frame: Screening,baseline, months 5 and 9

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 19772448Bergenstal RM, Freemantle N, Leyk M, Cutler GB Jr, Hayes RP, Muchmore DB. Does availability of AIR insulin increase insulin use and improve glycemic control in patients with type 2 diabetes? Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S45-52. doi: 10.1089/dia.2009.0028.
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

60 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 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 60 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 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 60 sites in United States, Canada, Brazil, Denmark, India 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 assess acceptance of insulin therapy (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT00330473, 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.