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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348374
• Other study ID #: A2171093
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: March 2, 2010
• Start date: June 2006
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	Pfizer Investigational Site	San Juan
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bartlett	Tennessee
United States	Pfizer Investigational Site	Bend	Oregon
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Bensalem	Pennsylvania
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	East Syracuse	New York
United States	Pfizer Investigational Site	El Paso	Texas
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Foot Hill Ranch	California
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Greenbrae	California
United States	Pfizer Investigational Site	Greenville	North Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Gurnee	Illinois
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Honululu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Idaho Falls	Idaho
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Kettering	Ohio
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Los Gatos	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Malvern	Arkansas
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Morehead City	North Carolina
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Mateo	California
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Statesville	North Carolina
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Virginia Beach	Virginia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	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.	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No
Secondary	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at Week 24.	Week 24	No
Secondary	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	Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.	Week 24	No
Secondary	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	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.	Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No
Secondary	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at 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.	Baseline, Week 12	No
Secondary	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at 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.	Baseline, Week 24	No
Secondary	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	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.	Baseline, Week 12, Week 24	No
Secondary	Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests	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.	Week 12, Week 24	No
Secondary	Change From Baseline Weight at Each Visit	Change = mean body weight at observation minus mean body weight at Baseline.	Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No
Secondary	Change From Baseline in Fasting Plasma Lipids	Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.	Baseline, Week 12, Week 24	No
Secondary	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	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, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No
Secondary	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Dose of inhaled insulin prior to each meal at each visit.	Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No
Secondary	Number of Subjects With Hypoglycemic Events	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.	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Yes
Secondary	Number of Total Hypoglycemic Events	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.	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Yes
Secondary	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	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.	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Yes
Secondary	Crude Hypoglycemic Event Rate	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.	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Yes
Secondary	Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)	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.	Week 4, Week 24	No
Secondary	Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to 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.	Week 4, Week 24	No
Secondary	Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.	Baseline, Week 12, Week 24	No
Secondary	Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.	Baseline, Week 12, Week 24	No

External Links

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