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Trial record 1 of 1 for:    NCT00348374
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Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00348374
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Results First Submitted Date  ICMJE August 3, 2009
Results First Posted Date  ICMJE March 16, 2010
Last Update Posted Date March 16, 2010
Study Start Date  ICMJE June 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment [ Time Frame: Baseline, Week 24 (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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
Primary Endpoint: The change in A1C from baseline to Week 24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • Secondary endpoints include, but are not limited to:
  • oChange in A1C from baseline at each visit
  • oPercent of subjects that attain an A1C < 7.0%, < 6.5% and < 6.0% at Week 24
  • oPercent of subjects that attain A1C targets of <7%, < 6.5%, < 6.0% at Week 24
  • without an episode of severe hypoglycemia
  • oChange from baseline in fasting and 2-hour postprandial glucose at each visit
  • as determined by 8-point self-monitored blood glucose profiles
  • oChange from baseline in fasting and postprandial plasma glucose, lipids, and
  • markers of CV risk as determined by standardized meal tolerance tests performed
  • at Week 12 and Week 24
  • oChange from baseline in weight at each visit
  • oChange from baseline in fasting plasma lipids at Weeks 12 and 24
  • oChange from baseline in insulin glargine dose at each visit
  • (office and/or phone)
  • oChange in baseline prandial insulin dose (at each meal) at each visit
  • oThe prevalence and severity of hypoglycemia
  • oChange from baseline in patient treatment satisfaction (as assessed
  • by Patient Satisfaction of Insulin Treatment [PSIT] Questionnaire) at
  • Week 4 and 24
  • oChange in patient treatment satisfaction (as assessed by PSIT Questionnaire)
  • from Week 4 to Week 24
  • oChange from baseline in 24-hour mean glucose values, and glycemic variability
  • measured by CGMS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Insulin Lispro
  • 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.
    Intervention: Drug: Exubera
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
191
Original Enrollment  ICMJE
 (submitted: June 30, 2006)
360
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00348374
Other Study ID Numbers  ICMJE A2171093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP