Diabetes Mellitus, Type 2Phase 3NCT00391209

Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder and intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 42 sites in 9 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 randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral… 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?: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder and intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 379 participants
Where: 42 sitesin 9 countries
Study dates: Oct 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 mellitus for at least 6 months
Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
Patients who have been treated with the following regimen:
One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
AND
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
AND
are candidates for insulin therapy, in the opinion of the investigator.

Who cannot join

Pregnancy
Smoker
History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
Diagnosed with pneumonia in the 3 months prior to screening
Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
History of renal transplantation

Show all 9Show fewer

History of lung transplantation
Active or untreated malignancy
Treated with Incretin mimetics

Trial locations and contacts

42 sites in 9 countries.

Country

City, postcode or hospital

42 sites in 9 countries

United States17 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.
Austin, Texas, 78731
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Biddeford, Maine, 04005
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Greenville, South Carolina, 29605
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96813
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Idaho Falls, Idaho, 83404
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Minneapolis, Minnesota, 55416
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New Orleans, Louisiana, 70121
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New Port Richey, Florida, 34652
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Renton, Washington, 98057
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78229
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Santa Ana, California, 92705
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South Miami, Florida, 33143
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Stratford, New Jersey, 08084
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Tacoma, Washington, 98405
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Washington D.C., District of Columbia, 20010

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Spain6 sites

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A Coruña, 15006
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Alicante, 03114
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Alzira, 46600
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Granada, 18014
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Palma de Mallorca, 07198
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Requena, 46340

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Belgium4 sites

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Bruges, 8000
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Brussels, 1070
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Leuven, 3000
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Liège, 4000

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France4 sites

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La Roche-sur-Yon, 85925
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La Rochelle, 17019
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Rouen, 76031
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Valenciennes, 59322

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India3 sites

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Ahmedabad, 380006
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Bangalore, 560052
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Chennai, 600116

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Puerto Rico3 sites

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Caguas, 00726
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Ponce, 00717-2075
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Rio Piedras, 00921

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Austria2 sites

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Vienna, 1090
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Vienna, A-1030

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Mexico2 sites

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Guadalajara, 44670
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Monterrey, 64060

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Argentina1 site

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Buenos Aires, 1012

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About this study

Official title: A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.

Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

Conditions: Diabetes Mellitus, Type 2
Being tested: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder, intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
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.

simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation PowderDrug
Also called LY041001
patient specific dose, inhaled, before meals,6 months
intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation PowderDrug
Also called LY 041001
patient specific dose, inhaled, before meals, 6 months

Study groups in NCT00391209
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
2	Experimental	Not described Receives: Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

What is being measured

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

Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Measured: 6 months

Secondary outcomes (9)

Mean change in HbA1c from baseline to various endpoints.
Measured: 6 months
Patient safety
Measured: throughout the study
Patient reported outcome from W-BQ12
Measured: screening,baseline,month 6
Treatment satisfaction
Measured: 6 months
Insulin dose
Measured: throughout the study
Patient reported outcome from DSC-R
Measured: screening,baseline, month 6
Patient reported outcome from DTSQS
Measured: screening,baseline, month 6
Patient reported outcome from IDSQ
Measured: Month 1, 2 and 6
Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
Measured: baseline, screening, month 6

Timeline

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

Oct 2006May 2008

First posted23 Oct 2006 (estimated)
Study startOct 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: 379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391209
Sponsor's protocol ID: 9630
Other IDs: H7U-MC-IDAY
Status last verified: Mar 2018
First submitted: 19 Oct 2006
Last updated: 9 Mar 2018
Results posted: No

Publications

Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.
PubMed 20370840

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 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00391209
Acronym / sponsor ID: 9630
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 379 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Oct 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 23 Oct 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: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
2	Experimental	Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

Who may qualify

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

Key inclusion criteria (8 listed)

Type 2 diabetes mellitus for at least 6 months
Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
Patients who have been treated with the following regimen:
One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
AND

Key exclusion criteria (9 listed)

Pregnancy
Smoker
History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
Diagnosed with pneumonia in the 3 months prior to screening
Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry

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
simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation PowderAlso: LY041001patient specific dose, inhaled, before meals,6 months	Drug	1
intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation PowderAlso: LY 041001patient specific dose, inhaled, before meals, 6 months	Drug	2

Primary outcome

Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Time frame: 6 months

9 secondary outcomes

Mean change in HbA1c from baseline to various endpoints.
Time frame: 6 months
Patient safety
Time frame: throughout the study
Patient reported outcome from W-BQ12
Time frame: screening,baseline,month 6
Treatment satisfaction
Time frame: 6 months
Insulin dose
Time frame: throughout the study
Patient reported outcome from DSC-R
Time frame: screening,baseline, month 6
Patient reported outcome from DTSQS
Time frame: screening,baseline, month 6
Patient reported outcome from IDSQ
Time frame: Month 1, 2 and 6
Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
Time frame: baseline, screening, month 6

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 20370840Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.

Related trials for Diabetes Mellitus, Type 2

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
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Obesity
Not yet recruiting
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Type 2 Diabetes (T2DM), Endothelial Dysfunction

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

42 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 9 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 42 sites in United States, Spain, Belgium, France, India and 4 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?

Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach. (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 NCT00391209, 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.