A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00138671

First received: August 26, 2005

Last updated: January 25, 2010

Last verified: August 2009

History of Changes

Results First Received: September 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Diabetes Mellitus Chronic Obstructive Pulmonary Disease
Interventions:	Drug: Subcutaneous Insulin Drug: Inhaled Insulin

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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Participant Flow: Overall Study

	Inhaled Insulin	Subcutaneous Insulin
STARTED	59	46
COMPLETED	46	30
NOT COMPLETED	13	16
Death	0	3
Adverse Event	6	3
Lost to Follow-up	1	2
Withdrawal by Subject	3	5
Unknown	3	3

Baseline Characteristics

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Reporting Groups

	Description
Inhaled Insulin	Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin	Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Total	Total of all reporting groups

Baseline Measures

	Inhaled Insulin	Subcutaneous Insulin	Total
Number of Participants [units: participants]	59	46	105
Age, Customized [units: participants]
36 to 45 years	1	3	4
46 to 55 years	10	4	14
56 to 65 years	20	23	43
66 to 75 years	27	15	42
> 75 years	1	1	2
Gender [units: participants]
Female	17	9	26
Male	42	37	79
Primary Diagnosis (Diabetes Type I or II) ^[1] [units: participants]
Type I	7	6	13
Type II	52	40	92

[1]	Type I or Type II diabetes mellitus was defined using the American Diabetes Association criteria (2002).

Outcome Measures

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1. Primary:

Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ]

Show Outcome Measure 1

2. Primary:

Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ]

Show Outcome Measure 2

3. Secondary:

Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) [ Time Frame: Duration of the study ]

Show Outcome Measure 3

4. Secondary:

Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) [ Time Frame: Duration of the study ]

Show Outcome Measure 4

5. Secondary:

Other PFTs (Besides FEV1 and DLco) [ Time Frame: Duration of the study ]

Show Outcome Measure 5

6. Secondary:

Bronchodilator Responsiveness as Determined by the Change in FEV1 [ Time Frame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ]

Show Outcome Measure 6

7. Secondary:

Insulin Dose Responsiveness for FEV1 [ Time Frame: Baseline, Week 9, Week 51 ]

Show Outcome Measure 7

8. Secondary:

Insulin Dose Responsiveness for DLco [ Time Frame: Baseline, Week 9, Week 51 ]

Show Outcome Measure 8

9. Secondary:

Methacholine PC20 [ Time Frame: Duration of the study ]

Show Outcome Measure 9

10. Secondary:

Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used [ Time Frame: Duration of the study ]

Show Outcome Measure 10

11. Secondary:

Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]

Show Outcome Measure 11

12. Secondary:

Incidence of Severe COPD Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]

Show Outcome Measure 12

13. Secondary:

Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires [ Time Frame: Duration of the study ]

Show Outcome Measure 13

14. Secondary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52 ]

Show Outcome Measure 14

15. Secondary:

Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, Weeks 6, 12, 26, 39, 52 ]

Show Outcome Measure 15

16. Secondary:

Change From Baseline in Body Weight [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 ]

Show Outcome Measure 16

17. Secondary:

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ]

Hide Outcome Measure 17

Measure Type	Secondary
Measure Title	Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)
Measure Description	Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.
Time Frame	Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
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, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.

Reporting Groups

	Description
Inhaled Insulin	No text entered.
Subcutaneous Insulin	No text entered.

Measured Values

	Inhaled Insulin	Subcutaneous Insulin
Number of Participants Analyzed [units: participants]	51	43
Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight) [units: Units] Mean ± Standard Deviation
Week 1 (n=53, 40)	43.78 ± 22.20	48.18 ± 23.44
Week 2 (n=50, 41)	44.96 ± 22.50	48.04 ± 24.33
Week 3 (n=51, 39)	47.04 ± 24.36	50.53 ± 24.44
Week 4 (n=52, 41)	47.50 ± 25.94	50.30 ± 25.61
Week 6 (n=54, 40)	49.56 ± 26.61	51.34 ± 25.91
Week 9 (n=47, 35)	48.68 ± 28.61	56.72 ± 25.89
Week 12 (n=51, 41)	49.23 ± 28.46	52.32 ± 29.49
Week 18 (n=51, 40)	50.87 ± 29.32	53.83 ± 29.34
Week 26 (n=51, 38)	50.47 ± 28.83	55.78 ± 28.11
Week 39 (n=49, 35)	49.99 ± 29.00	53.10 ± 26.11
Week 52 (n=48, 34)	50.66 ± 30.63	53.39 ± 26.32

No statistical analysis provided for Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)

18. Secondary:

Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ]

Show Outcome Measure 18

19. Secondary:

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ]

Show Outcome Measure 19

20. Secondary:

Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ]

Show Outcome Measure 20

21. Secondary:

Lipids [ Time Frame: Duration of the study ]

Show Outcome Measure 21

22. Secondary:

Hypoglycemic Event Rates [ Time Frame: 0 to1 month to > 11 months ]

Show Outcome Measure 22

23. Secondary:

Severe Hypoglcyemic Event Rates [ Time Frame: 0 to 1 month to > 11 months ]

Show Outcome Measure 23

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
This study was terminated due to Pfizer's decision to stop marketing Exubera®. Due to inconsistency in concomitant medication data entry, interpretation of the event rates for non-severe exacerbations may be of limited clinical value.

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:	NCT00138671 History of Changes
Other Study ID Numbers:	A2171030
Study First Received:	August 26, 2005
Results First Received:	September 2, 2009
Last Updated:	January 25, 2010
Health Authority:	United States: Food and Drug Administration

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