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 A1C levels.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• 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.
• Drug: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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

• The change in A1C from baseline to Week 24
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Change 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*
  • Time Frame: 6 months
    Safety Issue?: No
• Change in A1C from baseline at each visit
  • Time Frame: 6 months
    Safety Issue?: No
• Percent of subjects that attain an A1C < 7.0%, < 6.5% and < 6.0% at Week 24
  • Time Frame: 6 months
    Safety Issue?: No
• Percent of subjects that attain A1C targets of <7%, < 6.5%,
  • Time Frame: 6 months
    Safety Issue?: No
• < 6.0% at Week 24 without an episode of severe hypoglycemia
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in fasting and 2-hour postprandial glucose at each Visit as determined by 8-point self-monitored blood glucose profiles
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in weight at each Visit
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in fasting plasma lipids at Weeks 12 and 24
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in insulin glargine dose at each Visit (office and/or phone)
  • Time Frame: 6 months
    Safety Issue?: No
• Change in baseline prandial insulin dose (at each meal) at each Visit
  • Time Frame: 6 months
    Safety Issue?: No
• The prevalence and severity of hypoglycemia
  • Time Frame: 6 months
    Safety Issue?: Yes
• Change from baseline in patient treatment satisfaction (as assessed by Patient Satisfaction of Insulin Treatment [PSIT] Questionnaire) at Week 4 and 24
  • Time Frame: 6 months
    Safety Issue?: No
• Change in patient treatment satisfaction (as assessed by PSIT Questionnaire) from Week 4 to Week 24
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in 24-hour mean glucose values, and glycemic variability measured by CGMS*
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Adults with type 2 diabetes on basal insulinLantus, 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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 19, 2008

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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