Trial Outcomes & Findings for Follow-Up Study for Exubera (NCT NCT00734591)
NCT ID: NCT00734591
Last Updated: 2012-10-23
Results Overview
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.
COMPLETED
7439 participants
Baseline from original trial up to Year 2 of this study
2012-10-23
Participant Flow
This study had retrospective and prospective components. Individuals who participated in Exubera-controlled trials that were still active in 2003 or later participated in the retrospective part of this study (Follow-Up Study for Exubera; FUSE). Individuals from sites participating in the prospective part of FUSE were eligible.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Retrospective Period
STARTED
|
3875
|
3564
|
|
Retrospective Period
COMPLETED
|
3875
|
3564
|
|
Retrospective Period
NOT COMPLETED
|
0
|
0
|
|
Screening for Prospective Period
STARTED
|
3875
|
3564
|
|
Screening for Prospective Period
COMPLETED
|
1358
|
1273
|
|
Screening for Prospective Period
NOT COMPLETED
|
2517
|
2291
|
|
Prospective Period
STARTED
|
1358
|
1273
|
|
Prospective Period
COMPLETED
|
1307
|
1229
|
|
Prospective Period
NOT COMPLETED
|
51
|
44
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Screening for Prospective Period
Site did not participate
|
1604
|
1488
|
|
Screening for Prospective Period
Patient at partic. site not enrolled
|
913
|
803
|
|
Prospective Period
Withdrawal by Subject
|
11
|
9
|
|
Prospective Period
Lost to Follow-up
|
37
|
33
|
|
Prospective Period
Study Terminated
|
1
|
0
|
|
Prospective Period
Other
|
2
|
2
|
Baseline Characteristics
Follow-Up Study for Exubera
Baseline characteristics by cohort
| Measure |
Previously Randomized to Exubera
n=3875 Participants
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.
|
Previously Randomized to Comparator
n=3564 Participants
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.
|
Total
n=7439 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1677 Participants
n=5 Participants
|
1557 Participants
n=7 Participants
|
3234 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2198 Participants
n=5 Participants
|
2007 Participants
n=7 Participants
|
4205 Participants
n=5 Participants
|
|
Smoking status
Never-smoker
|
2194 participants
n=5 Participants
|
2031 participants
n=7 Participants
|
4225 participants
n=5 Participants
|
|
Smoking status
Ever-smoker
|
1681 participants
n=5 Participants
|
1533 participants
n=7 Participants
|
3214 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline from original trial up to Year 2 of this studyPopulation: Entire study population: all randomized participants (retrospective).
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.
Outcome measures
| Measure |
Previously Randomized to Exubera
n=3875 Participants
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.
|
Previously Randomized to Comparator
n=3654 Participants
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.
|
|---|---|---|
|
Rate of Primary Lung Cancer Mortality
|
0.48 Deaths per 1000 patient years (PY)
Interval 0.17 to 1.04
|
0.17 Deaths per 1000 patient years (PY)
Interval 0.02 to 0.61
|
SECONDARY outcome
Timeframe: Baseline from original trial up to Year 2 of this studyPopulation: Subset of the entire study population who were 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.
Outcome measures
| Measure |
Previously Randomized to Exubera
n=1681 Participants
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.
|
Previously Randomized to Comparator
n=1533 Participants
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.
|
|---|---|---|
|
Rate of Primary Lung Cancer Mortality Among Former Smokers
|
0.94 Deaths per 1000 PY
Interval 0.3 to 2.18
|
0.41 Deaths per 1000 PY
Interval 0.05 to 1.48
|
SECONDARY outcome
Timeframe: Baseline from original trial up to Year 2 of this studyPopulation: Entire study population
The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
Outcome measures
| Measure |
Previously Randomized to Exubera
n=3875 Participants
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.
|
Previously Randomized to Comparator
n=3564 Participants
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.
|
|---|---|---|
|
Rate of All-cause Mortality
|
6.03 Deaths per 1000 PY
Interval 4.75 to 7.55
|
7.37 Deaths per 1000 PY
Interval 5.9 to 9.09
|
SECONDARY outcome
Timeframe: Baseline from original trial up to Year 2 of this studyPopulation: Entire study population
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.
Outcome measures
| Measure |
Previously Randomized to Exubera
n=3875 Participants
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.
|
Previously Randomized to Comparator
n=3564 Participants
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.
|
|---|---|---|
|
Rate of Primary Lung Cancer Diagnosis
|
1.07 Lung Cancer per 1000 PY
Interval 0.55 to 1.87
|
0.29 Lung Cancer per 1000 PY
Interval 0.06 to 0.84
|
Adverse Events
Previously Randomized to Exubera
Previously Randomized to Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER