This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Insulin glargine Drug: Inhaled Insulin (Exubera)

Participant Flow

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
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Reporting Groups

	Description
Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Participant Flow: Overall Study

	Inhaled Human Insulin	Insulin Glargine
STARTED	219	194
Received Treatment	212	190
COMPLETED	136	152
NOT COMPLETED	83	42
Adverse Event	7	1
Lack of Efficacy	1	3
Lost to Follow-up	10	4
Withdrawal by Subject	31	7
Unknown	27	23
Randomized but did not receive treatment	7	4

Baseline Characteristics

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Reporting Groups

	Description
Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Baseline Measures

	Inhaled Human Insulin	Insulin Glargine	Total
Number of Participants [units: participants]	212	190	402
Age, Customized [units: participants]
18 to 44 years	27	26	53
45 to 65 years	151	125	276
>=65 years	34	39	73
Gender [units: participants]
Female	92	84	176
Male	120	106	226

Outcome Measures

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1. Primary:

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population [ Baseline, Week 26 ]

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2. Secondary:

Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 [ Week 26 ]

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3. Secondary:

Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 [ Week 26 ]

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4. Secondary:

Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 [ Week 26 ]

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5. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 26 [ Baseline, Week 26 ]

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6. Secondary:

Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 [ Baseline, Week 26 ]

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7. Secondary:

Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 [ Baseline, Week 26 ]

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8. Secondary:

Change From Baseline in Lipids at Week 26 [ Baseline, Week 26 ]

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9. Secondary:

Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 [ Baseline, Week 26 ]

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10. Secondary:

Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 [ Baseline, Week 26 ]

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11. Secondary:

Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 [ Baseline, Week 26 ]

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12. Secondary:

Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 [ Baseline, Week 26 ]

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13. Secondary:

Number of Subjects With Hypoglycemic Events [ Months 1 to 7 ]

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14. Secondary:

Number of Total Hypoglycemic Events [ Months 1 to 7 ]

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15. Secondary:

Number of Total Subject Months of Treatment [ Months 1 to 7 ]

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16. Secondary:

Crude Hypoglycemic Event Rate [ Months 1 to 7 ]

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17. Secondary:

Number of Nocturnal Hypoglycemic Events [ Months 1 to 7 ]

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18. Secondary:

Change From Baseline in Body Weight at Week 26 [ Baseline, Week 26 ]

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19. Secondary:

Change From Baseline in Body Mass Index (BMI) at Week 26 [ Baseline, Week 26 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Body Mass Index (BMI) at Week 26
Measure Description	BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
Time Frame	Baseline, Week 26
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.

Reporting Groups

	Description
Inhaled Human Insulin	Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
Insulin Glargine	Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Measured Values

	Inhaled Human Insulin	Insulin Glargine
Number of Participants Analyzed [units: participants]	203	189
Change From Baseline in Body Mass Index (BMI) at Week 26 [units: kg/m2] Mean ± Standard Deviation	1.22 ± 1.66	0.80 ± 1.30

Statistical Analysis 1 for Change From Baseline in Body Mass Index (BMI) at Week 26

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0053
Mean Difference (Final Values) ^[4]	0.42
95% Confidence Interval	( 0.12 to 0.71 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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20. Other Pre-specified:

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS [ Baseline, Week 26 ]

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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 information 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
Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data were not summarized, and no statistical analyses were performed.

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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171095
Study First Received:	January 3, 2007
Results First Received:	July 30, 2009
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00418522 History of Changes
Health Authority:	United States: Food and Drug Administration