This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00418522
First received: January 3, 2007
Last updated: September 8, 2009
Last verified: July 2009
  Purpose

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin glargine
Drug: Inhaled Insulin (Exubera)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six Month, Open Label, 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 A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Lipids at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Total Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Total Subject Months of Treatment [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Crude Hypoglycemic Event Rate [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Nocturnal Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Mass Index (BMI) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]

Enrollment: 413
Study Start Date: March 2007
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
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Drug: Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Experimental: Exubera
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Drug: Inhaled Insulin (Exubera)
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • Screening HbA1c > 7.0%
  • Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria:

Smoking within last 6 months PFTs outside of range

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
  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: NCT00418522

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Pfizer Investigational Site
Concord, California, United States, 94520
Pfizer Investigational Site
Encino, California, United States, 91436
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Fullerton, California, United States, 92835
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Mission Viejo, California, United States, 92691
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
San Diego, California, United States, 92128
Pfizer Investigational Site
San Diego, California, United States, 92120
Pfizer Investigational Site
San Luis Obispo, California, United States, 93401
Pfizer Investigational Site
Spring Valley, California, United States, 91978
Pfizer Investigational Site
Stockton, California, United States, 95204
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
Pfizer Investigational Site
West Hills, California, United States, 91307
United States, Colorado
Pfizer Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
Chiefland, Florida, United States, 32626
Pfizer Investigational Site
Clearwater, Florida, United States, 33765
Pfizer Investigational Site
Hollywood, Florida, United States, 33023
Pfizer Investigational Site
Kissimmee, Florida, United States, 34741
Pfizer Investigational Site
Miami, Florida, United States, 33156
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
St. Cloud, Florida, United States, 34769
Pfizer Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045-3388
Pfizer Investigational Site
Woodstock, Georgia, United States, 30189
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
Pfizer Investigational Site
Hayden Lake, Idaho, United States, 83835
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40503
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Pfizer Investigational Site
Haverhill, Massachusetts, United States, 01830-6141
United States, Missouri
Pfizer Investigational Site
Springfield, Missouri, United States, 65807
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New York
Pfizer Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209-3734
Pfizer Investigational Site
Statesville, North Carolina, United States, 28625
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
Pfizer Investigational Site
Maumee, Ohio, United States, 43537-9402
Pfizer Investigational Site
Toledo, Ohio, United States, 43606
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Pfizer Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Pfizer Investigational Site
Melrose Park, Pennsylvania, United States, 19027
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29615
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Pfizer Investigational Site
Milan, Tennessee, United States, 38358
United States, Texas
Pfizer Investigational Site
Arlington, Texas, United States, 76014-2010
Pfizer Investigational Site
Beaumont, Texas, United States, 77701
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
El Paso, Texas, United States, 79935
Pfizer Investigational Site
Houston, Texas, United States, 77008
Pfizer Investigational Site
Houston, Texas, United States, 77083
Pfizer Investigational Site
San Antonio, Texas, United States, 78229-3900
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201-5018
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
United States, Washington
Pfizer Investigational Site
Federal Way, Washington, United States, 98003
United States, Wisconsin
Pfizer Investigational Site
Menomonee Falls, Wisconsin, United States, 53051
Puerto Rico
Pfizer Investigational Site
Carolina, Puerto Rico, 00983
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: NCT00418522     History of Changes
Other Study ID Numbers: A2171095
Study First Received: January 3, 2007
Results First Received: July 30, 2009
Last Updated: September 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Insulin Glargine Diabetes HbA1c

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

ClinicalTrials.gov processed this record on October 20, 2014