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

NCT00418522 | Completed Phase 4 Results

• 1 other identifier: A2171095
• Study Type: interventional
• Target: 413
• Locations: 2 countries
• Sites: 73

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin Glargine Diabetes HbA1c

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

  HbA1c lab value: Change = value at Week 26 minus value at Baseline.

  Baseline, Week 26

Secondary Outcomes (19)

• Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26

  Week 26

• Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

  Week 26

• Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26

  Week 26

• Change From Baseline in Fasting Plasma Glucose at Week 26

  Baseline, Week 26

• Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26

  Baseline, Week 26

Other Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS

  Baseline, Week 26

Study Arms (2)

Insulin glargine

ACTIVE COMPARATOR

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

Exubera

EXPERIMENTAL

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)

Interventions

Insulin glargine DRUG

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.

Insulin glargine

Inhaled Insulin (Exubera) DRUG

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.

Exubera

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

Pfizer Investigational Site

Phoenix, Arizona, 85051, United States

Location

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Tucson, Arizona, 85712, United States

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Concord, California, 94520, United States

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Encino, California, 91436, United States

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Fresno, California, 93720, United States

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Fullerton, California, 92835, United States

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Long Beach, California, 90806, United States

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Mission Viejo, California, 92691, United States

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Pasadena, California, 91105, United States

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San Diego, California, 92120, United States

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San Diego, California, 92128, United States

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San Luis Obispo, California, 93401, United States

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Spring Valley, California, 91978, United States

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Stockton, California, 95204, United States

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Walnut Creek, California, 94598, United States

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West Hills, California, 91307, United States

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Golden, Colorado, 80401, United States

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Waterbury, Connecticut, 06708, United States

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Newark, Delaware, 19713, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33765, United States

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Hollywood, Florida, 33023, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33156, United States

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Ocala, Florida, 34471, United States

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Saint Cloud, Florida, 34769, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30322, United States

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Lawrenceville, Georgia, 30045-3388, United States

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Lawrenceville, Georgia, 30045, United States

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Woodstock, Georgia, 30189, United States

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Boise, Idaho, 83702, United States

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Hayden Lake, Idaho, 83835, United States

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Indianapolis, Indiana, 46254, United States

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Overland Park, Kansas, 66211, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40213, United States

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Baton Rouge, Louisiana, 70808, United States

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New Orleans, Louisiana, 70121, United States

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Haverhill, Massachusetts, 01830-6141, United States

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Springfield, Missouri, 65807, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89104, United States

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Staten Island, New York, 10301, United States

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Charlotte, North Carolina, 28209-3734, United States

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Statesville, North Carolina, 28625, United States

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Winston-Salem, North Carolina, 27103, United States

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Kettering, Ohio, 45429, United States

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Maumee, Ohio, 43537-9402, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73103, United States

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Medford, Oregon, 97504, United States

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Melrose Park, Pennsylvania, 19027, United States

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Greenville, South Carolina, 29615, United States

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Greer, South Carolina, 29651, United States

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Spartanburg, South Carolina, 29303, United States

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Milan, Tennessee, 38358, United States

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Arlington, Texas, 76014-2010, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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El Paso, Texas, 79935, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77083, United States

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San Antonio, Texas, 78229-3900, United States

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San Antonio, Texas, 78229, United States

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Bennington, Vermont, 05201-5018, United States

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Richmond, Virginia, 23249, United States

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Federal Way, Washington, 98003, United States

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Menomonee Falls, Wisconsin, 53051, United States

Location

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Carolina, 00983, Puerto Rico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Exubera

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data were not summarized, and no statistical analyses were performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 5, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 28, 2018
• Results First Posted: September 4, 2009

Record last verified: 2018-08

Locations

US (72); PR (1)