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Can a puff of insulin replace a needle for diabetes?

NCT ID NCT00418522

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether inhaled insulin (Exubera) can control blood sugar as well as insulin glargine (Lantus) injections in adults with type 2 diabetes who are not well controlled on two or more oral medications. Participants will receive either inhaled insulin before meals or daily insulin injections for six months, alongside their usual oral agents. The main goal is to see how much each approach lowers HbA1c, a key marker of long-term blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inhaled insulin (Exubera) compared to insulin glargine (Lantus) injections
What this could lead to
If effective, inhaled insulin could offer a needle-free alternative for managing type 2 diabetes, potentially improving convenience and adherence.
What could go wrong
This is a Phase 4 trial, but results may not show a clear advantage over standard injections. Inhaled insulin may have side effects like cough or lung function changes, and it may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

413 people

The number who actually took part.

Start date

Mar 2007

Finished

Aug 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Pfizer Investigational Site

    Phoenix, Arizona, 85051, United States

  • Pfizer Investigational Site

    Tucson, Arizona, 85712, United States

  • Pfizer Investigational Site

    Concord, California, 94520, United States

  • Pfizer Investigational Site

    Encino, California, 91436, United States

  • Pfizer Investigational Site

    Fresno, California, 93720, United States

  • Pfizer Investigational Site

    Fullerton, California, 92835, United States

  • Pfizer Investigational Site

    Long Beach, California, 90806, United States

  • Pfizer Investigational Site

    Mission Viejo, California, 92691, United States

  • Pfizer Investigational Site

    Pasadena, California, 91105, United States

  • Pfizer Investigational Site

    San Diego, California, 92120, United States

  • Pfizer Investigational Site

    San Diego, California, 92128, United States

  • Pfizer Investigational Site

    San Luis Obispo, California, 93401, United States

  • Pfizer Investigational Site

    Spring Valley, California, 91978, United States

  • Pfizer Investigational Site

    Stockton, California, 95204, United States

  • Pfizer Investigational Site

    Walnut Creek, California, 94598, United States

  • Pfizer Investigational Site

    West Hills, California, 91307, United States

  • Pfizer Investigational Site

    Golden, Colorado, 80401, United States

  • Pfizer Investigational Site

    Waterbury, Connecticut, 06708, United States

  • Pfizer Investigational Site

    Newark, Delaware, 19713, United States

  • Pfizer Investigational Site

    Chiefland, Florida, 32626, United States

  • Pfizer Investigational Site

    Clearwater, Florida, 33765, United States

  • Pfizer Investigational Site

    Hollywood, Florida, 33023, United States

  • Pfizer Investigational Site

    Kissimmee, Florida, 34741, United States

  • Pfizer Investigational Site

    Miami, Florida, 33156, United States

  • Pfizer Investigational Site

    Ocala, Florida, 34471, United States

  • Pfizer Investigational Site

    Saint Cloud, Florida, 34769, United States

  • Pfizer Investigational Site

    Winter Park, Florida, 32789, United States

  • Pfizer Investigational Site

    Atlanta, Georgia, 30322, United States

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30045-3388, United States

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30045, United States

  • Pfizer Investigational Site

    Woodstock, Georgia, 30189, United States

  • Pfizer Investigational Site

    Boise, Idaho, 83702, United States

  • Pfizer Investigational Site

    Hayden Lake, Idaho, 83835, United States

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46254, United States

  • Pfizer Investigational Site

    Overland Park, Kansas, 66211, United States

  • Pfizer Investigational Site

    Topeka, Kansas, 66606, United States

  • Pfizer Investigational Site

    Lexington, Kentucky, 40503, United States

  • Pfizer Investigational Site

    Louisville, Kentucky, 40213, United States

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70808, United States

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70121, United States

  • Pfizer Investigational Site

    Haverhill, Massachusetts, 01830-6141, United States

  • Pfizer Investigational Site

    Springfield, Missouri, 65807, United States

  • Pfizer Investigational Site

    Omaha, Nebraska, 68131, United States

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89104, United States

  • Pfizer Investigational Site

    Staten Island, New York, 10301, United States

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28209-3734, United States

  • Pfizer Investigational Site

    Statesville, North Carolina, 28625, United States

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • Pfizer Investigational Site

    Kettering, Ohio, 45429, United States

  • Pfizer Investigational Site

    Maumee, Ohio, 43537-9402, United States

  • Pfizer Investigational Site

    Toledo, Ohio, 43606, United States

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73103, United States

  • Pfizer Investigational Site

    Medford, Oregon, 97504, United States

  • Pfizer Investigational Site

    Melrose Park, Pennsylvania, 19027, United States

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615, United States

  • Pfizer Investigational Site

    Greer, South Carolina, 29651, United States

  • Pfizer Investigational Site

    Spartanburg, South Carolina, 29303, United States

  • Pfizer Investigational Site

    Milan, Tennessee, 38358, United States

  • Pfizer Investigational Site

    Arlington, Texas, 76014-2010, United States

  • Pfizer Investigational Site

    Beaumont, Texas, 77701, United States

  • Pfizer Investigational Site

    Dallas, Texas, 75230, United States

  • Pfizer Investigational Site

    Dallas, Texas, 75231, United States

  • Pfizer Investigational Site

    Dallas, Texas, 75246, United States

  • Pfizer Investigational Site

    El Paso, Texas, 79935, United States

  • Pfizer Investigational Site

    Houston, Texas, 77008, United States

  • Pfizer Investigational Site

    Houston, Texas, 77083, United States

  • Pfizer Investigational Site

    San Antonio, Texas, 78229-3900, United States

  • Pfizer Investigational Site

    San Antonio, Texas, 78229, United States

  • Pfizer Investigational Site

    Bennington, Vermont, 05201-5018, United States

  • Pfizer Investigational Site

    Richmond, Virginia, 23249, United States

  • Pfizer Investigational Site

    Federal Way, Washington, 98003, United States

  • Pfizer Investigational Site

    Menomonee Falls, Wisconsin, 53051, United States

  • Pfizer Investigational Site

    Carolina, 00983, Puerto Rico

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