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Clinical Trials/NCT00418522
NCT00418522CompletedPhase 4

A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

Pfizer73 sites in 1 country413 target enrollmentStarted: March 1, 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Pfizer
Enrollment
413
Locations
73
Primary Endpoint
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • •Screening HbA1c > 7.0%
  • •Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria

  • •Smoking within last 6 months PFTs outside of range
  • •Type 1 diabetes mellitus
  • •Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • •Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit
  • •However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.

Arms & Interventions

Exubera

Experimental

Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Intervention: Inhaled Insulin (Exubera) (Drug)

Insulin glargine

Active Comparator

Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Intervention: Insulin glargine (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

Time Frame: Baseline, Week 26

HbA1c lab value: Change = value at Week 26 minus value at Baseline.

Secondary Outcomes

  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26(Week 26)
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26(Week 26)
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26(Week 26)
  • Change From Baseline in Fasting Plasma Glucose at Week 26(Baseline, Week 26)
  • Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26(Baseline, Week 26)
  • Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26(Baseline, Week 26)
  • Change From Baseline in Lipids at Week 26(Baseline, Week 26)
  • Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26(Baseline, Week 26)
  • Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26(Baseline, Week 26)
  • Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26(Baseline, Week 26)
  • Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26(Baseline, Week 26)
  • Number of Subjects With Hypoglycemic Events(Months 1 to 7)
  • Number of Total Hypoglycemic Events(Months 1 to 7)
  • Number of Total Subject Months of Treatment(Months 1 to 7)
  • Crude Hypoglycemic Event Rate(Months 1 to 7)
  • Number of Nocturnal Hypoglycemic Events(Months 1 to 7)
  • Change From Baseline in Body Weight at Week 26(Baseline, Week 26)
  • Change From Baseline in Body Mass Index (BMI) at Week 26(Baseline, Week 26)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (73)

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