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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00138671
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 30, 2005
Results First Posted : November 13, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Obstructive Pulmonary Disease Drug: Subcutaneous Insulin Drug: Inhaled Insulin Phase 3

Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
Study Start Date : January 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
Active Comparator: Subcutaneous Insulin Drug: Subcutaneous Insulin
Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Experimental: Inhaled Insulin Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.




Primary Outcome Measures :
  1. 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 ]
    FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).

  2. 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 ]
    DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).


Secondary Outcome Measures :
  1. Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) [ Time Frame: Duration of the study ]
    Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

  2. Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) [ Time Frame: Duration of the study ]
    Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

  3. Other PFTs (Besides FEV1 and DLco) [ Time Frame: Duration of the study ]
    Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.

  4. Bronchodilator Responsiveness as Determined by the Change in FEV1 [ Time Frame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ]
    Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.

  5. Insulin Dose Responsiveness for FEV1 [ Time Frame: Baseline, Week 9, Week 51 ]
    FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).

  6. Insulin Dose Responsiveness for DLco [ Time Frame: Baseline, Week 9, Week 51 ]
    DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).

  7. Methacholine PC20 [ Time Frame: Duration of the study ]
    Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.

  8. Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used [ Time Frame: Duration of the study ]
    All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.

  9. Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]
    Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

  10. Incidence of Severe COPD Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]
    Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

  11. Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires [ Time Frame: Duration of the study ]
    The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.

  12. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52 ]
    Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).

  13. Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, Weeks 6, 12, 26, 39, 52 ]
    Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).

  14. Change From Baseline in Body Weight [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 ]
    Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).

  15. 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 ]
    Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.

  16. 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 ]
    Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.

  17. 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 ]
    Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).

  18. 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 ]
    Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).

  19. Lipids [ Time Frame: Duration of the study ]
    Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.

  20. Hypoglycemic Event Rates [ Time Frame: 0 to1 month to > 11 months ]
    A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

  21. Severe Hypoglcyemic Event Rates [ Time Frame: 0 to 1 month to > 11 months ]
    An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
  • Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria:

  • Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138671


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00138671    
Other Study ID Numbers: A2171030
First Posted: August 30, 2005    Key Record Dates
Results First Posted: November 13, 2009
Last Update Posted: February 2, 2010
Last Verified: August 2009
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs