Trial Outcomes & Findings for Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents (NCT NCT00479258)
NCT ID: NCT00479258
Last Updated: 2018-10-01
Results Overview
No subjects were dosed therefore no data collected.
TERMINATED
PHASE3
2 participants
12 months
2018-10-01
Participant Flow
Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. Location = UNITED STATES.
Pfizer announced in Oct 2007 that it would stop marketing Exubera. At that time recruitment was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171083 was terminated and no further recruitment took place.
Participant milestones
| Measure |
Inhaled Insulin (Exubera)
No subjects received study medication.
|
Subcutaneous Insulin (Subject's Prescribed)
No subjects received study medication.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: No subjects were dosed therefore no participants for analysis.
No subjects were dosed therefore no data collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
Adverse Events
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 \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER