This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00418522
First received: January 3, 2007
Last updated: September 8, 2009
Last verified: July 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418522
Hide Study Locations
Hide Study LocationsLocations
| 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, 75230 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| 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 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 May 23, 2013