Trial · NCT00137046
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
NCT00137046, Phase 3, Terminated, Pfizer; results first posted 2010-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes. Trials, record NCT00137046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00137046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
- NCT number
- NCT00137046
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 582 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Subcutaneous Insulin, Inhaled Insulin
- First posted
- 2005-08-29
- Last updated
- 2010-02-18
- Results first posted
- 2010-01-26
- Limitations and caveats
Due to early termination of study, none of the subjects completed the study as planned. Subjects active at the time of study termination completed an end-of-study assessment and a 3-month follow-up visit.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline through Extension Follow-up Month 3 | Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value). |
| Primary | Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1) | Month 3 through Extension Follow-up 3 | Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed. |
| Primary | Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) | Baseline through Extension Follow-up Month 3 | Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity \[DLco\] measured in milliters/minutes/millimeters of mercury \[mL/min/mmHg\] at observation minus Baseline value). |
| Primary | Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco). | Month 3 through Extension Follow-up Month 3 | Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat DLco was performed. |
| Primary | Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1) | Week -2 through Extension Follow-up Month 6 or end of study | Annual rate of change in FEV1 calculated as slope over time \[visit\] for forced expiratory volume in 1 second measured as liters per year (L/yr). |
| Primary | Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) | Week -2 through Extension Follow-up Month 6 or end of study | Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr). |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline through Extension Follow-up Month 3 | Change from Baseline: mean of (value of Glycosylated Hemoglobin \[HbA1c\] at observation minus Baseline value). |
| Secondary | Hypoglycemic Event Rates | Month 1 through Extension Month 39 | A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment. |
| Secondary | Severe Hypoglycemic Event Rates | Month 1 through Extension Month 39 | Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months \* 100. |
| Secondary | Change From Baseline in Fasting Plasma Glucose | Baseline through Extension Follow-up Month 3 | Change from Baseline: mean of (value of fasting plasma glucose \[milligrams per deciliter (mg/dL)\] at observation minus Baseline value). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline through Extension Follow-up Month 3 | Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1. | liters | MEAN |
| PRIMARY | Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1) | Month 3 through Extension Follow-up 3 | FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | participants | NUMBER |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline through Extension Follow-up Month 3 | FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | percent | MEAN |
| SECONDARY | Hypoglycemic Event Rates | Month 1 through Extension Month 39 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | total events/subject months | NUMBER |
| SECONDARY | Severe Hypoglycemic Event Rates | Month 1 through Extension Month 39 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | events / subject months * 100 | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose | Baseline through Extension Follow-up Month 3 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | mg/dL | MEAN |
| SECONDARY | Change From Baseline Body Weight | Baseline through Extension Follow-up Month 3 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | kilograms | MEAN |
| SECONDARY | Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) | Month 3 through Extension Month 39 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | units | MEAN |
| SECONDARY | Total Daily Long-Acting Insulin Dose Adjusted for Body Weight | Month 3 through Extension Month 39 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | units/kg | MEAN |
| SECONDARY | Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) | Month 3 through Extension Month 39 | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | mg, units | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group876
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Baseline (n=283, 281) | 3.51 | Standard Deviation 0.76 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Baseline (n=283, 281) | 3.47 | Standard Deviation 0.78 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Month 3 (n=277, 263) | -0.04 | Standard Deviation 0.12 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Month 3 (n=277, 263) | -0.01 | Standard Deviation 0.12 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Month 6 (n=262, 273) | -0.05 | Standard Deviation 0.14 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Month 6 (n=262, 273) | -0.03 | Standard Deviation 0.13 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Month 9 (n=251, 264) | -0.06 | Standard Deviation 0.14 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Month 9 (n=251, 264) | -0.04 | Standard Deviation 0.13 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Inhaled Insulin | Month 12 (n=242, 259) | -0.08 | Standard Deviation 0.14 | liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Subcutaneous Insulin | Month 12 (n=242, 259) | -004 | Standard Deviation 0.13 | liters |
1 to 10 of 876Source ClinicalTrials.gov
See all 876 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Insulin | 291 | |
| Overall Study | STARTED | Subcutaneous Insulin | 291 | |
| Overall Study | Received Study Treatment | Inhaled Insulin | 290 | |
| Overall Study | Received Study Treatment | Subcutaneous Insulin | 290 | |
| Overall Study | COMPLETED | Inhaled Insulin | 192 | |
| Overall Study | COMPLETED | Subcutaneous Insulin | 198 | |
| Overall Study | NOT COMPLETED | Inhaled Insulin | 99 | |
| Overall Study | NOT COMPLETED | Subcutaneous Insulin | 93 |
Source ClinicalTrials.gov
Adverse events268
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 | Abdominal pain upper | Gastrointestinal disorders | Inhaled Insulin | 10 | 290 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Subcutaneous Insulin | 17 | 290 | |
| other | Diarrhoea | Gastrointestinal disorders | Inhaled Insulin | 36 | 290 | |
| other | Diarrhoea | Gastrointestinal disorders | Subcutaneous Insulin | 28 | 290 | |
| other | Nausea | Gastrointestinal disorders | Inhaled Insulin | 30 | 290 | |
| other | Nausea | Gastrointestinal disorders | Subcutaneous Insulin | 21 | 290 | |
| other | Vomiting | Gastrointestinal disorders | Inhaled Insulin | 20 | 290 | |
| other | Vomiting | Gastrointestinal disorders | Subcutaneous Insulin | 17 | 290 | |
| other | Asthenia | General disorders | Inhaled Insulin | 19 | 290 | |
| other | Asthenia | General disorders | Subcutaneous Insulin | 21 | 290 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 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 | 290 | 290 |
| Total, other adverse events | Subcutaneous Insulin | 289 | 290 |
| Total, serious adverse events | Inhaled Insulin | 50 | 290 |
| Total, serious adverse events | Subcutaneous Insulin | 65 | 290 |
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/NCT00137046
GET https://conductscience.org/api/trials/v1/NCT00137046/registered?page=2