Trial · NCT00139659
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
NCT00139659, Phase 3, Completed, Pfizer; results first posted 2010-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma. Trials, record NCT00139659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00139659
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
- NCT number
- NCT00139659
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 288 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Asthma, Diabetes Mellitus
- Interventions
- Inhaled Insulin, Subcutaneous Insulin
- First posted
- 2005-08-31
- Last updated
- 2010-06-02
- Results first posted
- 2010-05-12
- Limitations and caveats
Data for some secondary endpoints were not tabulated or analyzed for this study and some concomitant medication data were not accurately recorded and tabulated due to lack of resources resulting from scaling down of Exubera® development.
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) | Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52 | Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for forced expiratory volume in 1 second (FEV1) (liters per year \[L/yr\]) measured 30 minutes following the administration of albuterol. |
| Primary | Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco) | Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52 | Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol. |
| Primary | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Baseline through Week 52 Last Observation Carried Forward (LOCF) | Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value. |
| Primary | Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value. |
| Secondary | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value. |
| Secondary | Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF) | Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline. |
| Secondary | Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward | Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline. |
| Secondary | Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF) | Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline. |
| Secondary | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline. |
| Secondary | Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52 | Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as \[(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1\] multiplied by 100. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) | Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52 | Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration. | L/yr | MEAN |
| SECONDARY | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | liters | MEAN |
| SECONDARY | Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | ml/min/mmHg | MEAN |
| SECONDARY | Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward | Full analysis set (FAS); LOCF: last observation carried forward. | liters | MEAN |
| SECONDARY | Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | ml/min/mmHg | MEAN |
| SECONDARY | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | liters | MEAN |
| SECONDARY | Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52 | Full analysis set (FAS) | percent change in FEV1 | MEAN |
| SECONDARY | Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | percentage of FEV1 | MEAN |
| SECONDARY | Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin | Baseline, Week 9, Week 51 | Full analysis set (FAS) | liters | MEAN |
| SECONDARY | Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF) | Full analysis set (FAS); LOCF: last observation carried forward. | percent | MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group634
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) | Inhaled Insulin | -0.070 | Standard Error 0.020 | L/yr | |
| Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) | Subcutaneous Insulin | -0.035 | Standard Error 0.019 | L/yr | |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Baseline (141, 139) | 2.435 | Standard Error 0.748 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Baseline (141, 139) | 2.412 | Standard Error 0.727 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Week 1 (123, 125) | -0.057 | Standard Error 0.142 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Week 1 (123, 125) | -0.035 | Standard Error 0.131 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Week 2 (n=127, 117) | -0.065 | Standard Error 0.159 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Week 2 (n=127, 117) | -0.034 | Standard Error 0.150 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Week 3 (n=130, 121) | -0.067 | Standard Error 0.185 | liters |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Week 3 (n=130, 121) | -0.044 | Standard Error 0.171 | liters |
1 to 10 of 634Source ClinicalTrials.gov
See all 634 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Insulin | 146 | |
| Overall Study | STARTED | Subcutaneous Insulin | 141 | |
| Overall Study | COMPLETED | Inhaled Insulin | 106 | |
| Overall Study | COMPLETED | Subcutaneous Insulin | 123 | |
| Overall Study | NOT COMPLETED | Inhaled Insulin | 40 | |
| Overall Study | NOT COMPLETED | Subcutaneous Insulin | 18 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | Inhaled Insulin | 3 | 146 | |
| other | Conjunctivitis | Eye disorders | Subcutaneous Insulin | 9 | 141 | |
| other | Constipation | Gastrointestinal disorders | Inhaled Insulin | 4 | 146 | |
| other | Constipation | Gastrointestinal disorders | Subcutaneous Insulin | 8 | 141 | |
| other | Diarrhoea | Gastrointestinal disorders | Inhaled Insulin | 10 | 146 | |
| other | Diarrhoea | Gastrointestinal disorders | Subcutaneous Insulin | 6 | 141 | |
| other | Nausea | Gastrointestinal disorders | Inhaled Insulin | 12 | 146 | |
| other | Nausea | Gastrointestinal disorders | Subcutaneous Insulin | 8 | 141 | |
| other | Vomiting | Gastrointestinal disorders | Inhaled Insulin | 8 | 146 | |
| other | Vomiting | Gastrointestinal disorders | Subcutaneous Insulin | 5 | 141 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Insulin | ||
| Total, all-cause mortality | Subcutaneous Insulin | ||
| Total, other adverse events | Inhaled Insulin | 140 | 146 |
| Total, other adverse events | Subcutaneous Insulin | 136 | 141 |
| Total, serious adverse events | Inhaled Insulin | 21 | 146 |
| Total, serious adverse events | Subcutaneous Insulin | 13 | 141 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Inhaled Insulin vs Subcutaneous Insulin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00139659
GET https://conductscience.org/api/trials/v1/NCT00139659/registered?page=2