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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

Change From Baseline in Fasting Plasma Glucose at 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

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7. Secondary:

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

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8. Secondary:

Change From Baseline in Lipids at 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

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10. Secondary:

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

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11. Secondary:

Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at 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

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13. Secondary:

Number of Subjects With Hypoglycemic Events

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14. Secondary:

Number of Total Hypoglycemic Events

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15. Secondary:

Number of Total Subject Months of Treatment

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16. Secondary:

Crude Hypoglycemic Event Rate

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17. Secondary:

Number of Nocturnal Hypoglycemic Events

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18. Secondary:

Change From Baseline in Body Weight at Week 26

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19. Secondary:

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

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20. Other Pre-specified:

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

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Serious Adverse Events

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Other Adverse Events

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Frequency Threshold

Threshold above which other adverse events are reported	5%

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.

Other Adverse Events

	Inhaled Human Insulin	Insulin Glargine
Total, other (not including serious) adverse events
# participants affected	177	142
Eye disorders
Vision blurred ^†^A # participants affected / at risk	14/212 (6.60%)	6/190 (3.16%)
Gastrointestinal disorders
Diarrhoea ^† # participants affected / at risk	12/212 (5.66%)	8/190 (4.21%)
Nausea ^† # participants affected / at risk	21/212 (9.91%)	15/190 (7.89%)
General disorders
Asthenia ^† # participants affected / at risk	28/212 (13.21%)	17/190 (8.95%)
Fatigue ^† # participants affected / at risk	13/212 (6.13%)	11/190 (5.79%)
Injection site haematoma ^† # participants affected / at risk	0/212 (0.00%)	13/190 (6.84%)
Oedema peripheral ^† # participants affected / at risk	11/212 (5.19%)	9/190 (4.74%)
Infections and infestations
Influenza ^† # participants affected / at risk	9/212 (4.25%)	10/190 (5.26%)
Nasopharyngitis ^† # participants affected / at risk	12/212 (5.66%)	13/190 (6.84%)
Upper respiratory tract infection ^† # participants affected / at risk	23/212 (10.85%)	29/190 (15.26%)
Investigations
Weight increased ^† # participants affected / at risk	17/212 (8.02%)	9/190 (4.74%)
Metabolism and nutrition disorders
Hypoglycaemia ^† # participants affected / at risk	144/212 (67.92%)	83/190 (43.68%)
Nervous system disorders
Dizziness ^† # participants affected / at risk	40/212 (18.87%)	29/190 (15.26%)
Headache ^† # participants affected / at risk	29/212 (13.68%)	17/190 (8.95%)
Tremor ^† # participants affected / at risk	67/212 (31.60%)	43/190 (22.63%)
Respiratory, thoracic and mediastinal disorders
Cough ^† # participants affected / at risk	18/212 (8.49%)	6/190 (3.16%)
Skin and subcutaneous tissue disorders
Hyperhidrosis ^† # participants affected / at risk	35/212 (16.51%)	21/190 (11.05%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA (v12.0)

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