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

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”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment
  • Time Frame: Baseline, Week 24 (End of Treatment)
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24
  • Time Frame: Week 24
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests
  • Time Frame: Baseline, Week 12, Week 24
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in Fasting Plasma Lipids
  • Time Frame: Baseline, Week 12, Week 24
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Number of Subjects With Hypoglycemic Events
  • Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
    Safety Issue?: Yes
• Number of Total Hypoglycemic Events
  • Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• Crude Hypoglycemic Event Rate
  • Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
    Safety Issue?: Yes
• Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)
  • Time Frame: Week 4, Week 24
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)
  • Time Frame: Baseline, Week 12, Week 24
    Safety Issue?: No
• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348374

Study ID Number: A2171093

ClinicalTrials.gov Identifier: NCT00348374

Health Authority: United States: Food and Drug Administration

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