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

August 26, 2005
February 3, 2010
May 2002
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
The primary outcome is to assess the toleration and safety of EXUBERA® (inhaled insulin) compared to subcutaneous insulin therapy the effects if any on measures of pulmonary function.
Complete list of historical versions of study NCT00137046 on ClinicalTrials.gov Archive Site
  • 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 ]
Secondary endpoints include HbA1c, fasting plasma glucose, body weight, lipids, insulin dose, incidence and severity off hypoglycemic episodes, cough questionnaire, and baseline and transition dyspnea index.
Not Provided
Not Provided
 
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: Subcutaneous Insulin
    Subcutaneous insulin with dose adjusted according to premeal blood glucose
  • Drug: Inhaled Insulin
    Inhaled insulin with dose adjusted according to premeal blood glucose
  • Active Comparator: Subcutaneous Insulin
    Intervention: Drug: Subcutaneous Insulin
  • Experimental: Inhaled Insulin
    Intervention: Drug: Inhaled Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
582
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Mexico
 
NCT00137046
A2171022
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP