Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00527397

First received: September 7, 2007

Last updated: October 5, 2009

Last verified: July 2009

History of Changes

Results First Received: July 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
Intervention:	Drug: CP-464,005

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 centers in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human [rDNA origin] Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects.

Reporting Groups

	Description
All Subjects With Type 1 or Type 2 Diabetes Mellitus	All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.

Participant Flow: Overall Study

	All Subjects With Type 1 or Type 2 Diabetes Mellitus
STARTED	24
COMPLETED	0
NOT COMPLETED	24
Adverse Event	3
Lack of Efficacy	1
Protocol Violation	1
Withdrawal by Subject	6
Study terminated by sponsor	13

Baseline Characteristics

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Reporting Groups

	Description
All Subjects With Type 1 or Type 2 Diabetes Mellitus	All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.

Baseline Measures

	All Subjects With Type 1 or Type 2 Diabetes Mellitus
Number of Participants [units: participants]	24
Age [units: years] Mean ± Standard Deviation	55.2 ± 15.0
Gender [units: participants]
Female	13
Male	11

Outcome Measures

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1. Primary:

Self-Monitoring Blood Glucose Levels: Change From Baseline [ Time Frame: One year ]

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2. Secondary:

Daily Inhaled Insulin Dose [ Time Frame: Up to 26 weeks ]

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3. Secondary:

The Values of Hemoglobin A1c:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment ]

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4. Secondary:

The Value of Fasting Plasma Glucose:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26 ]

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5. Secondary:

The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin [ Time Frame: 0 month to 12 months ]

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6. Secondary:

The Values of Forced Expiratory Volume at 1 Second:Change From Baseline [ Time Frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 ]

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7. Secondary:

The Values of Forced Vital Capacity:Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment ]

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8. Secondary:

The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment ]

Show Outcome Measure 8

9. Secondary:

Insulin Antibody Levels : Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, End of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00527397 History of Changes
Other Study ID Numbers:	A2171105
Study First Received:	September 7, 2007
Results First Received:	July 15, 2009
Last Updated:	October 5, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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