Follow-Up Study for Exubera | NCT00734591

NCT00734591

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Previously treated with Exubera			Drug: Exubera
Previously treated with comparator		Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.	Other: Randomized diabetes therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exubera	Drug	Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Primary Lung Cancer Mortality	Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.	Baseline from original trial up to Year 2 of this study

Secondary Outcomes

Measure	Description	Time Frame
Rate of Primary Lung Cancer Mortality Among Former Smokers	Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Bay Minette	Alabama	36507	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31331907	Derived	Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

No data available

No data is available for this block.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
BG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean age at original trial

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054.8± 12.1 BG00154.7± 12.6 BG00254.8± 12.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001677 BG0011557 BG002

Smoking status

Reported as number of participants who never smoked (never-smoker) and those who have ever smoked (ever-smoker) includes former smokers and current smokers.

Number

participants

Title

Denominators

Categories

Never-smoker

Title	Measurements
	BG0002194 BG0012031

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Primary Lung Cancer Mortality

Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.

Entire study population: all randomized participants (retrospective).

Posted

Number

95% Confidence Interval

Deaths per 1000 patient years (PY)

Baseline from original trial up to Year 2 of this study

ID	Title	Description
OG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
OG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Units	Counts
Participants	OG0003875 OG0013654

Title

Denominators

Categories

Title	Measurements
	OG0000.48(0.17 to 1.04) OG0010.17(0.02 to 0.61)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Exact method	2.81			2-Sided	95	0.50	28.46			Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.	No	Superiority or Other

Secondary

Rate of Primary Lung Cancer Mortality Among Former Smokers

Subset of the entire study population who were former smokers.

Posted

Number

95% Confidence Interval

Deaths per 1000 PY

Baseline from original trial up to Year 2 of this study

ID	Title	Description
OG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
OG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Secondary

Rate of All-cause Mortality

The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.

Entire study population

Posted

Number

95% Confidence Interval

Deaths per 1000 PY

Baseline from original trial up to Year 2 of this study

ID	Title	Description
OG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
OG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Units	Counts
Participants

Secondary

Rate of Primary Lung Cancer Diagnosis

The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.

Entire study population

Posted

Number

95% Confidence Interval

Lung Cancer per 1000 PY

Baseline from original trial up to Year 2 of this study

ID	Title	Description
OG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
OG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Previously Randomized to Exubera	Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.			0	0	0	0
EG001	Previously Randomized to Comparator	Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.			0	0	0	0

Detection and/or reporting bias possible in continuous analysis (presented here) of lung cancer mortality and lung cancer incidence endpoints. Study had insufficient power to draw clear statistical conclusions due to small number of events.

Certain Agreements

ID	Term
D003920	Diabetes Mellitus

ID	Term
C473734	Exubera

Units	Counts
Participants	OG0003875 OG0013564

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases