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

July 20, 2026 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
413

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85051
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
    • California
      • Concord, California, United States, 94520
        • Pfizer Investigational Site
      • Encino, California, United States, 91436
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Mission Viejo, California, United States, 92691
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
      • San Luis Obispo, California, United States, 93401
        • Pfizer Investigational Site
      • Spring Valley, California, United States, 91978
        • Pfizer Investigational Site
      • Stockton, California, United States, 95204
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
      • West Hills, California, United States, 91307
        • Pfizer Investigational Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • Florida
      • Chiefland, Florida, United States, 32626
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33023
        • Pfizer Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33156
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • Pfizer Investigational Site
      • Winter Park, Florida, United States, 32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, United States, 30045-3388
        • Pfizer Investigational Site
      • Woodstock, Georgia, United States, 30189
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Pfizer Investigational Site
      • Hayden Lake, Idaho, United States, 83835
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Topeka, Kansas, United States, 66606
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • Pfizer Investigational Site
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830-6141
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Pfizer Investigational Site
    • New York
      • Staten Island, New York, United States, 10301
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209-3734
        • Pfizer Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
      • Maumee, Ohio, United States, 43537-9402
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43606
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Melrose Park, Pennsylvania, United States, 19027
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Pfizer Investigational Site
    • Tennessee
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014-2010
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79935
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77008
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77083
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229-3900
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201-5018
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Insulin glargine
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.
Drug: Insulin glargine
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.
Experimental: Exubera
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.
Drug: Inhaled Insulin (Exubera)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Time Frame: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Time Frame: Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
Time Frame: Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
Time Frame: Week 26
Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.
Week 26
Change From Baseline in Fasting Plasma Glucose at Week 26
Time Frame: Baseline, Week 26
Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change From Baseline in Lipids at Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
Time Frame: Baseline, Week 26
CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
Time Frame: Baseline, Week 26
CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Number of Subjects With Hypoglycemic Events
Time Frame: Months 1 to 7
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.
Months 1 to 7
Number of Total Hypoglycemic Events
Time Frame: Months 1 to 7
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.
Months 1 to 7
Number of Total Subject Months of Treatment
Time Frame: Months 1 to 7
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.
Months 1 to 7
Crude Hypoglycemic Event Rate
Time Frame: Months 1 to 7
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.
Months 1 to 7
Number of Nocturnal Hypoglycemic Events
Time Frame: Months 1 to 7
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.
Months 1 to 7
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline, Week 26
Body weight value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Body Mass Index (BMI) at Week 26
Time Frame: Baseline, Week 26
BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Time Frame: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A2171095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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