A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00391027
First received: October 19, 2006
Last updated: October 20, 2009
Last verified: August 2009
  Purpose

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine (Lantus®)
Drug: Inhaled Human Insulin (Exubera®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in HbA1c Prior to Week 26 [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18 ] [ Designated as safety issue: No ]
  • Number of Subjects With HbA1c < 6.5 % [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With HbA1c < 7.0 % [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With HbA1c < 8.0 % [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) Level [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With Hypoglycemic Events by Severity [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Number of Events of Nocturnal Hypoglycemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects Discontinued Due to Insufficient Clinical Response [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]

Enrollment: 261
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin Glargine (Lantus®) Drug: Insulin Glargine (Lantus®)
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
Active Comparator: Inhaled Human Insulin (Exubera®) Drug: Inhaled Human Insulin (Exubera®)
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Mellitus, Type 2 on oral agents
  • Age > 30 years

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease
  • Smoking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391027

  Show 62 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: NCT00391027     History of Changes
Other Study ID Numbers: A2171084
Study First Received: October 19, 2006
Results First Received: August 5, 2009
Last Updated: October 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
type 2 diabetes, insulin, glycemic control

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

ClinicalTrials.gov processed this record on April 14, 2014