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Diabetes Mellitus, Type 2Phase 4NCT00418522

This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

A Phase 4 study testing Insulin glargine and Inhaled Insulin (Exubera) in people with Diabetes Mellitus, Type 2, run by Pfizer at 73 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin glargine and Inhaled Insulin (Exubera)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
73 sitesin 2 countries
Study dates
Mar 2007to Aug 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • Screening HbA1c > 7.0%
  • Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Who cannot join

  • Smoking within last 6 months PFTs outside of range
  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.

Trial locations and contacts

73 sites in 2 countries.

73 sites in 2 countries

United States72 sites

  • Pfizer Investigational Site

    Arlington, Texas, 76014-2010

  • Pfizer Investigational Site

    Atlanta, Georgia, 30322

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70808

  • Pfizer Investigational Site

    Beaumont, Texas, 77701

  • Pfizer Investigational Site

    Bennington, Vermont, 05201-5018

  • Pfizer Investigational Site

    Boise, Idaho, 83702

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28209-3734

  • Pfizer Investigational Site

    Chiefland, Florida, 32626

  • Pfizer Investigational Site

    Clearwater, Florida, 33765

  • Pfizer Investigational Site

    Concord, California, 94520

  • Pfizer Investigational Site

    Dallas, Texas, 75230

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    El Paso, Texas, 79935

  • Pfizer Investigational Site

    Encino, California, 91436

  • Pfizer Investigational Site

    Federal Way, Washington, 98003

  • Pfizer Investigational Site

    Fresno, California, 93720

  • Pfizer Investigational Site

    Fullerton, California, 92835

  • Pfizer Investigational Site

    Golden, Colorado, 80401

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615

  • Pfizer Investigational Site

    Greer, South Carolina, 29651

  • Pfizer Investigational Site

    Haverhill, Massachusetts, 01830-6141

  • Pfizer Investigational Site

    Hayden Lake, Idaho, 83835

  • Pfizer Investigational Site

    Hollywood, Florida, 33023

  • Pfizer Investigational Site

    Houston, Texas, 77008

  • Pfizer Investigational Site

    Houston, Texas, 77083

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46254

  • Pfizer Investigational Site

    Kettering, Ohio, 45429

  • Pfizer Investigational Site

    Kissimmee, Florida, 34741

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89104

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30045-3388

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30045

  • Pfizer Investigational Site

    Lexington, Kentucky, 40503

  • Pfizer Investigational Site

    Long Beach, California, 90806

  • Pfizer Investigational Site

    Louisville, Kentucky, 40213

  • Pfizer Investigational Site

    Maumee, Ohio, 43537-9402

  • Pfizer Investigational Site

    Medford, Oregon, 97504

  • Pfizer Investigational Site

    Melrose Park, Pennsylvania, 19027

  • Pfizer Investigational Site

    Menomonee Falls, Wisconsin, 53051

  • Pfizer Investigational Site

    Miami, Florida, 33156

  • Pfizer Investigational Site

    Milan, Tennessee, 38358

  • Pfizer Investigational Site

    Mission Viejo, California, 92691

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70121

  • Pfizer Investigational Site

    Newark, Delaware, 19713

  • Pfizer Investigational Site

    Ocala, Florida, 34471

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73103

  • Pfizer Investigational Site

    Omaha, Nebraska, 68131

  • Pfizer Investigational Site

    Overland Park, Kansas, 66211

  • Pfizer Investigational Site

    Pasadena, California, 91105

  • Pfizer Investigational Site

    Phoenix, Arizona, 85051

  • Pfizer Investigational Site

    Richmond, Virginia, 23249

  • Pfizer Investigational Site

    Saint Cloud, Florida, 34769

  • Pfizer Investigational Site

    San Antonio, Texas, 78229-3900

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Diego, California, 92120

  • Pfizer Investigational Site

    San Diego, California, 92128

  • Pfizer Investigational Site

    San Luis Obispo, California, 93401

  • Pfizer Investigational Site

    Spartanburg, South Carolina, 29303

  • Pfizer Investigational Site

    Spring Valley, California, 91978

  • Pfizer Investigational Site

    Springfield, Missouri, 65807

  • Pfizer Investigational Site

    Staten Island, New York, 10301

  • Pfizer Investigational Site

    Statesville, North Carolina, 28625

  • Pfizer Investigational Site

    Stockton, California, 95204

  • Pfizer Investigational Site

    Toledo, Ohio, 43606

  • Pfizer Investigational Site

    Topeka, Kansas, 66606

  • Pfizer Investigational Site

    Tucson, Arizona, 85712

  • Pfizer Investigational Site

    Walnut Creek, California, 94598

  • Pfizer Investigational Site

    Waterbury, Connecticut, 06708

  • Pfizer Investigational Site

    West Hills, California, 91307

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103

  • Pfizer Investigational Site

    Winter Park, Florida, 32789

  • Pfizer Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

Puerto Rico1 site

  • Pfizer Investigational Site

    Carolina, 00983

Other trials in Puerto Rico

About this study

Official title: A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

Being tested
Insulin glargine, Inhaled Insulin (Exubera)
Keywords
Insulin Glargine Diabetes HbA1c
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.

  • Insulin glargineDrug

    Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

  • Inhaled Insulin (Exubera)Drug

    Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Study groups in NCT00418522
Study groupRoleWhat they receive
Insulin glargineActive comparatorInsulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Receives: Drug: Insulin glargine
ExuberaExperimentalInitiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Receives: Drug: Inhaled Insulin (Exubera)

What is being measured

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

  1. Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

    HbA1c lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

Secondary outcomes (18)

  1. Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26

    Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.

    Measured: Week 26

  2. Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

    Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.

    Measured: Week 26

  3. Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26

    Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.

    Measured: Week 26

  4. Change From Baseline in Fasting Plasma Glucose at Week 26

    Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  5. Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26

    Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  6. Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26

    Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  7. Change From Baseline in Lipids at Week 26

    Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  8. Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26

    CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  9. Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26

    CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  10. Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26

    24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  11. Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26

    SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  12. Number of Subjects With Hypoglycemic Events

    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

    Measured: Months 1 to 7

  13. Number of Total Hypoglycemic Events

    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.

    Measured: Months 1 to 7

  14. Number of Total Subject Months of Treatment

    Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

    Measured: Months 1 to 7

  15. Crude Hypoglycemic Event Rate

    crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.

    Measured: Months 1 to 7

  16. Number of Nocturnal Hypoglycemic Events

    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.

    Measured: Months 1 to 7

  17. Change From Baseline in Body Weight at Week 26

    Body weight value: Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

  18. Change From Baseline in Body Mass Index (BMI) at Week 26

    BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.

    Measured: Baseline, Week 26

Timeline

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

  1. First posted5 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00418522
Sponsor's protocol ID
A2171095
Status last verified
Jul 2025
First submitted
3 Jan 2007
Last updated
11 Aug 2026
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine and Inhaled Insulin (Exubera) in people with Diabetes Mellitus, Type 2, run by Pfizer at 73 sites in 2 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population (time frame: Baseline, Week 26). 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 NCT00418522.

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 11 Aug 2026.

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