A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00282971

First received: January 26, 2006

Last updated: September 11, 2009

Last verified: July 2009

History of Changes

Results First Received: February 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus Type 2
Interventions:	Other: Standard of Care Drug: Inhaled Insulin (Exubera)

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)

Reporting Groups

	Description
Inhaled Insulin	Inhaled insulin plus oral therapy
Standard of Care	Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Participant Flow: Overall Study

	Inhaled Insulin	Standard of Care
STARTED	180	171
COMPLETED	146	149
NOT COMPLETED	34	22

Baseline Characteristics

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Reporting Groups

	Description
Inhaled Insulin	Inhaled insulin plus oral therapy
Standard of Care	Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Total	Total of all reporting groups

Baseline Measures

	Inhaled Insulin	Standard of Care	Total
Number of Participants [units: participants]	180	171	351
Age, Customized [units: participants]
<18 years	0	0	0
Between 18 and 44 years	12	6	18
Between 45 and 64 years	112	113	225
>=65 years	56	52	108
Gender [units: participants]
Female	76	80	156
Male	104	91	195

Outcome Measures

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1. Primary:

Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: 4, 12 and 24 weeks ]

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2. Secondary:

Percentage of Participants Achieving Glycemic Control by Visit [ Time Frame: 4, 12 and 24 weeks ]

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3. Secondary:

Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ]

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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 mo 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
Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of 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:	NCT00282971 History of Changes
Other Study ID Numbers:	A2171063, EXACTA
Study First Received:	January 26, 2006
Results First Received:	February 11, 2009
Last Updated:	September 11, 2009
Health Authority:	United States: Food and Drug Administration

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