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Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136916
First received: August 25, 2005
Last updated: February 12, 2010
Last verified: December 2009
History of Changes
  Purpose

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

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
 Drug: Inhaled Insulin
Drug: Subcutaneous 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 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Month 3 through extension Month 60 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in FEV1 [ Time Frame: Baseline through extension follow up Month 3 ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in FEV1 [ Time Frame: Week -2 through extension follow up Month 3 or end of study ] [ Designated as safety issue: Yes ]
  • Summary of ≥ 15 % Decliners in FEV1 [ Time Frame: Month 3 through extension follow up Month 3 ] [ Designated as safety issue: Yes ]
  • Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Week -2 through extension follow up Month 3 or end of study ] [ 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 DLco [ Time Frame: Month 3 through extension follow up Month 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Forced Vital Capacity (FVC) [ Time Frame: Week -3 through extension follow up Month 3 or end of study ] [ Designated as safety issue: Yes ]
  • Total Lung Capacity (TLC) [ Time Frame: Baseline through extension follow up Month 3 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through extension follow up Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline through extension follow up Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in 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 36 ] [ Designated as safety issue: No ]
  • Total Daily Long-acting Insulin (Adjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ] [ Designated as safety issue: No ]
  • Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ] [ Designated as safety issue: No ]
  • Total Daily Short-acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ] [ Designated as safety issue: No ]
  • Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides [ Time Frame: Week -4 through Month 24 ] [ Designated as safety issue: No ]
  • Hypoglycemic Event Rates [ Time Frame: Month 1 through extension Month 36 ] [ Designated as safety issue: No ]
  • Severe Hypoglycemic Event Rates [ Time Frame: Month 1 through extension Month 36 ] [ 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 ]
  • 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 3 or end of study ] [ Designated as safety issue: Yes ]
  • High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits [ Time Frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36 ] [ Designated as safety issue: Yes ]
  • High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits [ Time Frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36 ] [ Designated as safety issue: Yes ]
  • Insulin Antibodies [ Time Frame: Baseline through extension Month 36 ] [ Designated as safety issue: Yes ]

Enrollment: 635
Study Start Date: June 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Insulin
Inhalable short-acting insulin
 Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose
Other Name: Exubera
Active Comparator: Subcutaneous insulin Drug: Subcutaneous insulin
Subcutaneous 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 A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • COPD
  • Asthma
  • Smoking Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136916

  Show 92 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00136916     History of Changes
Other Study ID Numbers: A2171029
Study First Received: August 25, 2005
Results First Received: December 10, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013