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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00348374
First received: June 30, 2006
Last updated: March 2, 2010
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
 Drug: Insulin Lispro
Drug: Exubera
 Phase 3

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 Phase 3b, Randomized, Open-Label, Parallel Group, Multicenter Trial Assessing The Efficacy Of Exubera Vs. Lispro Introduced Into A Lantus Based Regimen In Suboptimally Controlled Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment [ Time Frame: Baseline, Week 24 (End of Treatment) ] [ Designated as safety issue: No ]
    Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.


Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.

  • Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at 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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.

  • Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles [ Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.

  • Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.

  • Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.

  • Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.

  • Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
    Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)[mg/L], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.

  • Change From Baseline Weight at Each Visit [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Change = mean body weight at observation minus mean body weight at Baseline.

  • Change From Baseline in Fasting Plasma Lipids [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.

  • Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone) [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).

  • Baseline Prandial Insulin Dose (at Each Meal) at Each Visit [ Time Frame: Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Dose of inhaled insulin prior to each meal at each visit.

  • Number of Subjects With Hypoglycemic Events [ Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: Yes ]
    Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.

  • Number of Total Hypoglycemic Events [ Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: Yes ]
    Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.

  • Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment [ Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: Yes ]
    Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated * days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.

  • Crude Hypoglycemic Event Rate [ Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: Yes ]
    Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.

  • Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) [ Time Frame: Week 4, Week 24 ] [ Designated as safety issue: No ]
    Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.

  • Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24 [ Time Frame: Week 4, Week 24 ] [ Designated as safety issue: No ]

    Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction.

    Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24.


  • Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS) [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.

  • Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS) [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.


Enrollment: 191
Study Start Date: June 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Drug: 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.
Experimental: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348374

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-307
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006-2850
United States, Arkansas
Pfizer Investigational Site
Malvern, Arkansas, United States, 72104
United States, California
Pfizer Investigational Site
Foot Hill Ranch, California, United States, 92610
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
Los Gatos, California, United States, 95032-3739
Pfizer Investigational Site
San Diego, California, United States, 92120
Pfizer Investigational Site
San Mateo, California, United States, 94401-3805
Pfizer Investigational Site
Tustin, California, United States, 92780
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80209
United States, Connecticut
Pfizer Investigational Site
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010-2934
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32205
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Miami, Florida, United States, 33156
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
Pfizer Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31904
Pfizer Investigational Site
Decatur, Georgia, United States, 30034-1680
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
Pfizer Investigational Site
Honululu, Hawaii, United States, 96814
United States, Idaho
Pfizer Investigational Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60607
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
United States, Iowa
Pfizer Investigational Site
Des Moines, Iowa, United States, 50314
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40503
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21234-4607
Pfizer Investigational Site
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
Flint, Michigan, United States, 48532
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55454-1321
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, New York
Pfizer Investigational Site
East Syracuse, New York, United States, 13057
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
Pfizer Investigational Site
Morehead City, North Carolina, United States, 28557
Pfizer Investigational Site
Statesville, North Carolina, United States, 28625
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Pfizer Investigational Site
Bend, Oregon, United States, 97701
United States, Pennsylvania
Pfizer Investigational Site
Bensalem, Pennsylvania, United States, 19020
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
Pfizer Investigational Site
Bartlett, Tennessee, United States, 38133
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Arlington, Texas, United States, 76012
Pfizer Investigational Site
Arlington, Texas, United States, 76014
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
El Paso, Texas, United States, 79935
Pfizer Investigational Site
Houston, Texas, United States, 77004
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
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23462
United States, Washington
Pfizer Investigational Site
Renton, Washington, United States, 98055
Pfizer Investigational Site
Spokane, Washington, United States, 99208
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Puerto Rico
Pfizer Investigational Site
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00348374     History of Changes
Other Study ID Numbers: A2171093
Study First Received: June 30, 2006
Results First Received: August 3, 2009
Last Updated: March 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
type two diabetes, insulin, HbA1c

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

ClinicalTrials.gov processed this record on May 23, 2013