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

NCT ID: NCT00348374

Last Updated: 2010-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Lispro

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.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type 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

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.

Group Type EXPERIMENTAL

Exubera

Intervention Type 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.

Interventions

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Insulin Lispro

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.

Intervention Type DRUG

Exubera

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* lung disease
* current smoking or discontinued smoking within past 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Pfizer Investigational Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Malvern, Arkansas, United States

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Foot Hill Ranch, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Los Gatos, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Tustin, California, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Honululu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Des Moines, Iowa, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Flint, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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East Syracuse, New York, United States

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Greenville, North Carolina, United States

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Morehead City, North Carolina, United States

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Statesville, North Carolina, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Bensalem, Pennsylvania, United States

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Greenville, South Carolina, United States

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Bartlett, Tennessee, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Bennington, Vermont, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Pfizer Investigational Site

San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171093&StudyName=Exubera%20vs%20Lispro%20in%20a%20Lantus-based%20Regimen%20for%20improved%20glycemic%20control%20in%20Type%202%20Diabetes

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

Other Identifiers

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A2171093

Identifier Type: -

Identifier Source: org_study_id

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