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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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Month 3 through Extension Follow-up 3 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: Yes ]
  • Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco). [ Time Frame: Month 3 through Extension Follow-up Month 3 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Severe Hypoglycemic Event Rates [ Time Frame: Month 1 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline Body Weight [ Time Frame: Baseline through Extension Follow-up Month 3 ] [ Designated as safety issue: No ]
  • Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Long-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Total Daily Short-Acting Insulin Dose Adjusted for Body Weight [ Time Frame: Month 3 through Extension Month 39 ] [ Designated as safety issue: No ]
  • Baseline Dyspnea Index (BDI) [ Time Frame: Week - 1 ] [ Designated as safety issue: Yes ]
  • Transition Dyspnea Index (TDI) [ Time Frame: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study ] [ Designated as safety issue: Yes ]
  • Lipids [ Time Frame: Week -4 through Month 24 ] [ Designated as safety issue: No ]
  • Cough Questionnaire [ Time Frame: Week 0 and if indicated through Extension Follow up Month 3 ] [ Designated as safety issue: No ]
  • Forced Vital Capacity (FVC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ] [ Designated as safety issue: Yes ]
  • Total Lung Capacity (TLC) [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ] [ Designated as safety issue: Yes ]
  • Insulin Antibodies [ Time Frame: Baseline through Extension Month 39 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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:
No publications provided

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
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014