Diabetes Mellitus, Type 2Phase 3NCT00437112

Evaluate the Efficacy and Safety of Insulin Compared to Glargine 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 19 sites in 5 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 Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. 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: 142 participants
Where: 19 sitesin 5 countries
Study dates: Feb 2007to 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
Insulin naive
One or more oral antihyperglycemic medications
HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
Non-smoker

Who cannot join

Taking a TZD dose greater than what is indicated
Have not taken insulin within 6 months of entry into study
Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
Have had pneumonia in the 3 months prior to study entry
Systemic glucocorticoid therapy

Show all 11Show fewer

Clinical signs or symptoms of liver disease, acute or chronic hepatitis
History of renal transplantation
Have an active or untreated malignancy
Have a current diagnosis or past history of clinically relevant pulmonary disease
Taking or have taken exenatide during the 6 weeks prior to study entry

Trial locations and contacts

19 sites in 5 countries.

Country

City, postcode or hospital

19 sites in 5 countries

United States6 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.
Albuquerque, New Mexico, 87108
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.
Greenbrae, California, 94904
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.
New Braunfels, Texas, 78130
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.
San Antonio, Texas, 78229
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.
Toms River, New Jersey, 08753
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.
Topeka, Kansas, 66606

Other trials in United States

Spain5 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.
Barakaldo, 48903
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.
Dos Hermanas, 41014
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.
Madrid, 28006
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.
Requena, 46340
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.
Sabadell, 08208

Other trials in Spain

India4 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.
Indore, 452 003
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.
Kochi, 682026
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.
Pune, 411005
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.
Vellore, 632 004

Other trials in India

Brazil2 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.
Porto Alegre, 90035-003
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.
São Paulo, 04025-011

Other trials in Brazil

Puerto Rico2 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.
Manati, 00674
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.
San Juan, 00907

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents

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, 24 weeks
Insulin GlargineDrug
patient specific dose, injectable, before meals, 24 weeks

Study groups in NCT00437112
Study group	Role	What they receive
1	Experimental	4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period Receives: Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine
2	Experimental	4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period 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.

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.
Measured: 56 weeks

Secondary outcomes (14)

Mean change in HbA1c from baseline to various timepoints
Measured: 56 weeks
Insulin dose requirements
Measured: 56 weeks
Patient-reported outcomes of W-BQ12
Measured: screening,baseline, week 12,24, and 48
Hypoglycemia rate
Measured: throughout the study
Changes in body weight
Measured: every visit
Adverse events
Measured: throughout the study
Safety as assessed by total pulmonary function testing and fasting lipid profile
Measured: throughout the study
Assess inhaler reliability.
Measured: throughout the study
Patient Reported outcomes of DSC-R
Measured: screening,baseline, week 12,24, and 48
Patient reported outcomes of DTSQS
Measured: screening,baseline, week 12, 24 and 48
Patient reported outcome of IDSQ
Measured: week 12, 24, and 48
Patient reported outcome of preference questionnaire
Measured: week 48
Patient reported outcome of Expectations About Insulin Therapy Questionnaire
Measured: screening,baseline
Patient reported outcome of Experience with Insulin Therapy Questionnaire
Measured: week 12, 24 and 48

Timeline

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

Feb 2007May 2008

First posted19 Feb 2007 (estimated)
Study startFeb 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Crossover
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00437112
Sponsor's protocol ID: 9631
Other IDs: H7U-MC-IDAZ
Status last verified: Mar 2018
First submitted: 16 Feb 2007
Last updated: 9 Mar 2018
Results posted: No

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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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
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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, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents
ClinicalTrials.gov ID: NCT00437112
Acronym / sponsor ID: 9631
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Alkermes, Inc.
Study start: Feb 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 19 Feb 2007 (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: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Human Insulin Inhalation Powder, Drug: Insulin Glargine4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period
2	Experimental	Drug: Human Insulin Inhalation Powder, Drug: Insulin Glargine4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period

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
Insulin naive
One or more oral antihyperglycemic medications
HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
Non-smoker

Key exclusion criteria (11 listed)

Taking a TZD dose greater than what is indicated
Have not taken insulin within 6 months of entry into study
Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
Have had pneumonia in the 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
Human Insulin Inhalation PowderAlso: LY041001patient specific dose, inhaled, before meals, 24 weeks	Drug	1, 2
Insulin Glarginepatient specific dose, injectable, before meals, 24 weeks	Drug	1, 2

Primary outcome

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.
Time frame: 56 weeks

14 secondary outcomes

Mean change in HbA1c from baseline to various timepoints
Time frame: 56 weeks
Insulin dose requirements
Time frame: 56 weeks
Patient-reported outcomes of W-BQ12
Time frame: screening,baseline, week 12,24, and 48
Hypoglycemia rate
Time frame: throughout the study
Changes in body weight
Time frame: every visit
Adverse events
Time frame: throughout the study
Safety as assessed by total pulmonary function testing and fasting lipid profile
Time frame: throughout the study
Assess inhaler reliability.
Time frame: throughout the study
Patient Reported outcomes of DSC-R
Time frame: screening,baseline, week 12,24, and 48
Patient reported outcomes of DTSQS
Time frame: screening,baseline, week 12, 24 and 48
Patient reported outcome of IDSQ
Time frame: week 12, 24, and 48
Patient reported outcome of preference questionnaire
Time frame: week 48
Patient reported outcome of Expectations About Insulin Therapy Questionnaire
Time frame: screening,baseline
Patient reported outcome of Experience with Insulin Therapy Questionnaire
Time frame: week 12, 24 and 48

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.

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 from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

19 sites in 5 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 19 sites in 5 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 11 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 19 sites in United States, Spain, India, Brazil, Puerto Rico. 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?

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint. (time frame: 56 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 NCT00437112.

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; AzTrials last refreshed its copy on 7 Nov 2026.