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
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: 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
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014