Trial · NCT00308737

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

NCT00308737, Phase 3, Completed, Mannkind Corporation; results first posted 2014-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes. Trials, record NCT00308737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00308737

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
NCT number: NCT00308737
Status: Completed
Phases: Phase 3
Enrollment: 2,053 participants, actual
Lead sponsor: Mannkind Corporation
Conditions: Diabetes, Type 1, Diabetes, Type 2
Interventions: Technosphere® Insulin Inhalation Powder, Usual Care
First posted: 2006-03-30
Last updated: 2014-10-16
Results first posted: 2014-10-16

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care	Baseline to Month 24	Change from Baseline to End of Study in FEV1 by MMRM
Primary	FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care	Baseline to Month 24	FEV1 decrease of ≥ 15% from Baseline value at last measurement
Secondary	Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care	Baseline to Month 24	Change from Baseline to last measurement(Month 24) in FEV1
Secondary	Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM	Baseline to Month 24	Change from Baseline to Month 24 in FVC by MMRM
Secondary	Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM	Baseline to Month 24	Change from baseline to Month 24 in TLC by MMRM
Secondary	Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM	Baseline to Month 24	Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM
Secondary	Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	FVC Decrease of ≥15% from Baseline Value at Last Measurement
Secondary	Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	TLC Decrease of ≥ 15% from Baseline Value at Last Measurement
Secondary	Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement
Secondary	Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement	Baseline to Month 24	Hemoglobin-corrected DLco decrease of \>3 ml/min/mmHg from baseline value at last measurement

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care	Baseline to Month 24	Intention to Treat (ITT)	liters	MEAN
SECONDARY	Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care	Baseline to Month 24	Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)	liters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM	Baseline to Month 24	Intention to Treat (ITT)	liters	MEAN
SECONDARY	Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM	Baseline to Month 24	participants in ITT population with available data	liters	MEAN
SECONDARY	Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM	Baseline to Month 24	participants in ITT population with available data	mL/min/mmHg	MEAN
SECONDARY	Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	participants in ITT population with available data	participants	NUMBER
SECONDARY	Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	participants in ITT population with available data	Participants	NUMBER
SECONDARY	Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement	Baseline to Month 24	participants in ITT population with available data	Participants	NUMBER
SECONDARY	Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement	Baseline to Month 24	participants in ITT population with available data	Participants	NUMBER
SECONDARY	Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care	Baseline to Month 24	Intention to treat (ITT) with last observation carried forward (LOCF)	percentage	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care	Technosphere® Insulin	-0.16	Standard Deviation 0.208	liters
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care	Usual Care	-0.12	Standard Deviation 0.211	liters
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care	Technosphere® Insulin	-0.128	95% Confidence Interval -0.144 to -0.113	liters
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care	Usual Care	-0.092	95% Confidence Interval -0.107 to -0.077	liters
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM	Technosphere® Insulin	-0.14	Standard Deviation 0.242	liters
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM	Usual Care	-0.11	Standard Deviation 0.262	liters
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM	Non-diabetes	-0.09	Standard Deviation 0.210	liters
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM	Technosphere® Insulin	-0.05	Standard Deviation 0.321	liters
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM	Usual Care	-0.07	Standard Deviation 0.322	liters
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM	Non-diabetes	-0.02	Standard Deviation 0.297	liters

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Technosphere® Insulin	938
Overall Study	STARTED	Usual Care	951
Overall Study	STARTED	Non-diabetes	164
Overall Study	COMPLETED	Technosphere® Insulin	475
Overall Study	COMPLETED	Usual Care	662
Overall Study	COMPLETED	Non-diabetes	127
Overall Study	NOT COMPLETED	Technosphere® Insulin	463
Overall Study	NOT COMPLETED	Usual Care	289
Overall Study	NOT COMPLETED	Non-diabetes	37

Source ClinicalTrials.gov

Adverse events513

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
other	Upper respiratory tract infection	Infections and infestations	Technosphere® Insulin	119	923
other	Upper respiratory tract infection	Infections and infestations	Usual Care	143	949
other	Upper respiratory tract infection	Infections and infestations	Non-diabetes	35	163
other	Nasopharyngitis	Infections and infestations	Technosphere® Insulin	67	923
other	Nasopharyngitis	Infections and infestations	Usual Care	69	949
other	Nasopharyngitis	Infections and infestations	Non-diabetes	14	163
other	Hypoglycaemia	Metabolism and nutrition disorders	Technosphere® Insulin	365	923
other	Hypoglycaemia	Metabolism and nutrition disorders	Usual Care	370	949
other	Hypoglycaemia	Metabolism and nutrition disorders	Non-diabetes	0	163
other	Cough	Respiratory, thoracic and mediastinal disorders	Technosphere® Insulin	257	923

1 to 10 of 513Source ClinicalTrials.gov

See all 513 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Technosphere® Insulin
Total, all-cause mortality	Usual Care
Total, all-cause mortality	Non-diabetes
Total, other adverse events	Technosphere® Insulin	559	923
Total, other adverse events	Usual Care	472	949
Total, other adverse events	Non-diabetes	47	163
Total, serious adverse events	Technosphere® Insulin	92	923
Total, serious adverse events	Usual Care	91	949
Total, serious adverse events	Non-diabetes	5	163

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
Technosphere® Insulin vs Usual Care: FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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