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Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137046
First received: August 26, 2005
Last updated: February 3, 2010
Last verified: December 2009
  Purpose

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.


Condition Intervention Phase
Diabetes Mellitus, Type 1 Drug: Subcutaneous Insulin Drug: Inhaled Insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus: A Long-Term, 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 Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline through Extension Follow-up Month 3 ]
  • Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Month 3 through Extension Follow-up 3 ]
  • Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline through Extension Follow-up Month 3 ]
  • Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco). [ Time Frame: Month 3 through Extension Follow-up Month 3 ]
  • Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ]
  • Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ]

Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through Extension Follow-up Month 3 ]
  • Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ]
  • Severe Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline through Extension Follow-up Month 3 ]
  • Change From Baseline Body Weight [ Time Frame: Baseline through Extension Follow-up Month 3 ]
  • Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ]
  • Total Daily Long-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ]
  • Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ]
  • Total Daily Short-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ]
  • Baseline Dyspnea Index (BDI) [ Time Frame: Week - 1 ]
  • Transition Dyspnea Index (TDI) [ Time Frame: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study ]
  • Lipids [ Time Frame: Week -4 through Month 24 ]
  • Cough Questionnaire [ Time Frame: Week 0 and if indicated through Extension Follow up Month 3 ]
  • Forced Vital Capacity (FVC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ]
  • Total Lung Capacity (TLC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ]
  • Insulin Antibodies [ Time Frame: Baseline through Extension Month 39 ]

Enrollment: 582
Study Start Date: May 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcutaneous Insulin Drug: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Experimental: Inhaled Insulin Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera. 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 A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137046

  Show 73 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: NCT00137046     History of Changes
Other Study ID Numbers: A2171022
Study First Received: August 26, 2005
Results First Received: December 7, 2009
Last Updated: February 3, 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 29, 2017