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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00138671
First received: August 26, 2005
Last updated: January 25, 2010
Last verified: August 2009
History of Changes

August 26, 2005
January 25, 2010
January 2003
September 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Change from baseline in FEV1 and DLco measured 30 minutes following the administration of ipratropium at clinic visits throughout the study.
Complete list of historical versions of study NCT00138671 on ClinicalTrials.gov Archive Site
  • Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Other PFTs (Besides FEV1 and DLco) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Bronchodilator Responsiveness as Determined by the Change in FEV1 [ Time Frame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ] [ Designated as safety issue: Yes ]
  • Insulin Dose Responsiveness for FEV1 [ Time Frame: Baseline, Week 9, Week 51 ] [ Designated as safety issue: Yes ]
  • Insulin Dose Responsiveness for DLco [ Time Frame: Baseline, Week 9, Week 51 ] [ Designated as safety issue: Yes ]
  • Methacholine PC20 [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 0 to 1 week to > 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of Severe COPD Exacerbations [ Time Frame: 0 to 1 week to > 9 months ] [ Designated as safety issue: Yes ]
  • Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, Weeks 6, 12, 26, 39, 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Hypoglycemic Event Rates [ Time Frame: 0 to1 month to > 11 months ] [ Designated as safety issue: No ]
  • Severe Hypoglcyemic Event Rates [ Time Frame: 0 to 1 month to > 11 months ] [ Designated as safety issue: No ]
Other PFTs (besides FEV1 and DLco), bronchodilator responsiveness, PFTs measured before and after insulin administration, COPD exacerbations, COPD medication use, diabetes control (HbA1c, hypoglycemic events).
Not Provided
Not Provided
 
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
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

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Chronic Obstructive Pulmonary Disease
  • 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.
  • 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.
  • 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
105
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 77 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   Costa Rica,   Germany
 
NCT00138671
A2171030
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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