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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:
ClinicalTrials.gov Identifier:
NCT00138671
First Posted: August 30, 2005
Last Update Posted: February 2, 2010
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.
Information provided by:
Pfizer
  Purpose
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Condition Intervention Phase
Diabetes Mellitus Chronic Obstructive Pulmonary Disease Drug: Subcutaneous Insulin Drug: Inhaled Insulin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) [ Time Frame: Duration of the study ]
  • Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) [ Time Frame: Duration of the study ]
  • Other PFTs (Besides FEV1 and DLco) [ Time Frame: Duration of the study ]
  • Bronchodilator Responsiveness as Determined by the Change in FEV1 [ Time Frame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ]
  • Insulin Dose Responsiveness for FEV1 [ Time Frame: Baseline, Week 9, Week 51 ]
  • Insulin Dose Responsiveness for DLco [ Time Frame: Baseline, Week 9, Week 51 ]
  • Methacholine PC20 [ Time Frame: Duration of the study ]
  • Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used [ Time Frame: Duration of the study ]
  • Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]
  • Incidence of Severe COPD Exacerbations [ Time Frame: 0 to 1 week to > 9 months ]
  • Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires [ Time Frame: Duration of the study ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52 ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, Weeks 6, 12, 26, 39, 52 ]
  • Change From Baseline in Body Weight [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Lipids [ Time Frame: Duration of the study ]
  • Hypoglycemic Event Rates [ Time Frame: 0 to1 month to > 11 months ]
  • Severe Hypoglcyemic Event Rates [ Time Frame: 0 to 1 month to > 11 months ]

Enrollment: 105
Study Start Date: January 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 77 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 88 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00138671     History of Changes
Other Study ID Numbers: A2171030
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: September 2, 2009
Results First Posted: November 13, 2009
Last Update Posted: February 2, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Diabetes Mellitus
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs