Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

NCT00348374 | Completed Phase 3 Results

• 1 other identifier: A2171093
• Study Type: interventional
• Target: 191
• Locations: 2 countries
• Sites: 63

Brief Summary

The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.

Conditions

Diabetes Mellitus

Keywords

type two diabetes, insulin, HbA1c

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment

  Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.

  Baseline, Week 24 (End of Treatment)

Secondary Outcomes (20)

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24

  Week 24

• Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24

  Week 24

• Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles

  Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12

  Baseline, Week 12

Study Arms (2)

Insulin Lispro

ACTIVE COMPARATOR

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Drug: Insulin Lispro

Exubera

EXPERIMENTAL

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Drug: Exubera

Interventions

Insulin Lispro DRUG

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Insulin Lispro

Exubera DRUG

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Exubera

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

You may not qualify if:

• lung disease
• current smoking or discontinued smoking within past 6 months

Sponsors & Collaborators

• Pfizer: lead

Study Sites (63)

Pfizer Investigational Site

Birmingham, Alabama, 35294-307, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85006-2850, United States

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Malvern, Arkansas, 72104, United States

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Foot Hill Ranch, California, 92610, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Los Gatos, California, 95032-3739, United States

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San Diego, California, 92120, United States

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San Mateo, California, 94401-3805, United States

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Tustin, California, 92780, United States

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Denver, Colorado, 80209, United States

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New Britain, Connecticut, 06050, United States

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Washington D.C., District of Columbia, 20010-2934, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33156, United States

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West Palm Beach, Florida, 33401, United States

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Winter Park, Florida, 32789, United States

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Columbus, Georgia, 31904, United States

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Decatur, Georgia, 30034-1680, United States

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Honolulu, Hawaii, 96813, United States

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Honululu, Hawaii, 96814, United States

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Idaho Falls, Idaho, 83404, United States

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Chicago, Illinois, 60607, United States

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Gurnee, Illinois, 60031, United States

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Des Moines, Iowa, 50314, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40213, United States

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Baltimore, Maryland, 21234-4607, United States

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Bethesda, Maryland, 20817, United States

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Boston, Massachusetts, 02114, United States

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Flint, Michigan, 48532, United States

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Minneapolis, Minnesota, 55454-1321, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68131, United States

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East Syracuse, New York, 13057, United States

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Greenville, North Carolina, 27834, United States

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Morehead City, North Carolina, 28557, United States

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Statesville, North Carolina, 28625, United States

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Kettering, Ohio, 45429, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74104, United States

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Bend, Oregon, 97701, United States

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Bensalem, Pennsylvania, 19020, United States

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Greenville, South Carolina, 29615, United States

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Bartlett, Tennessee, 38133, United States

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Memphis, Tennessee, 38119, United States

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Arlington, Texas, 76012, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75230, 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, 77004, 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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Norfolk, Virginia, 23502, United States

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Virginia Beach, Virginia, 23462, United States

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Renton, Washington, 98055, United States

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Spokane, Washington, 99208, United States

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Milwaukee, Wisconsin, 53209, United States

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San Juan, 00936-5067, Puerto Rico

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Lispro; Exubera

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-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 sample size was too small to adequately address the inferential objectives of this study. Descriptive statistics for the PSIT Questionnaire and the markers of cardiovascular risk were not provided.

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 16, 2010
• Results First Posted: March 16, 2010

Record last verified: 2009-07

Locations

US (62); PR (1)