A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

This study has been terminated.

( See termination reason in detailed description. )

Study NCT00356421 Information provided by Pfizer

First Received on July 24, 2006. Last Updated on August 25, 2009 History of Changes

Results First Received: June 24, 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 1
Interventions:	Drug: Inhaled Human Insulin (Exubera®) Drug: Insulin lispro (Humalog)

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
A total of 340 subjects were planned to be randomized; 87 were screened and 58 were randomized to study treatment prior to study termination.

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 (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.

Reporting Groups

	Description
Exubera ®	Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
Insulin Lispro	Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.

Participant Flow: Overall Study

	Exubera ®	Insulin Lispro
STARTED	38	20
COMPLETED	6	3
NOT COMPLETED	32	17
Lack of Efficacy	3	0
Withdrawal by Subject	9	2
Related to study drug	15	12
Not related to study drug	5	3

Baseline Characteristics

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Reporting Groups

	Description
Exubera ®	Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
Insulin Lispro	Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.

Baseline Measures

	Exubera ®	Insulin Lispro	Total
Number of Participants [units: participants]	38	20	58
Age, Customized ^[1] [units: participants]
18 - 44 years	22	13	35
45 - 64 years	14	6	20
>=65 years	2	1	3
Gender [units: participants]
Female	17	6	23
Male	21	14	35

[1]	Safety population.

Outcome Measures

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1. Primary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) [ Time Frame: At 52 weeks ]

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2. Secondary:

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% [ Time Frame: At 52 weeks ]

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3. Secondary:

Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% [ Time Frame: At 52 weeks ]

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4. Secondary:

Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline [ Time Frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. ]

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5. Secondary:

Change From Baseline in FPG [ Time Frame: At 52 weeks or last observation ]

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6. Secondary:

Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ]

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7. Secondary:

Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ]

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8. Secondary:

Change From Baseline in Insulin Antibody Levels [ Time Frame: At weeks 24 and 52 or last observation. ]

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9. Secondary:

Change From Baseline in Body Weight [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ]

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10. Secondary:

Change From Baseline in Body Mass Index [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ]

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11. Secondary:

Change From Baseline in Basal Insulin Doses [ Time Frame: To 52 weeks ]

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12. Secondary:

Change From Baseline in Prandial Insulin Doses [ Time Frame: To 52 weeks ]

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13. Secondary:

Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) [ Time Frame: To 52 weeks. ]

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14. Secondary:

Change in Fasting Lipids From Baseline [ Time Frame: At weeks 24 and 52 or last observation ]

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15. Other Pre-specified:

Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: At weeks 6, 24, and 52 or last observation ]

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16. Other Pre-specified:

Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement [ Time Frame: At weeks 6, 24, and 52 or last observation ]

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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
As a result of Pfizer’s decision to stop marketing Exubera ®, this study was terminated. Due to the early termination of the study and the low number of subjects who completed, no descriptive statistics for efficacy endpoints are provided.

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:	NCT00356421 History of Changes
Other Study ID Numbers:	A2171035
Study First Received:	July 24, 2006
Results First Received:	June 24, 2009
Last Updated:	August 25, 2009
Health Authority:	United States: Food and Drug Administration