NCT00391027CompletedPhase 4
A Six Month, Open-Label Outpatient, 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 261
- Locations
- 62
- Primary Endpoint
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Study Overview
Brief Summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with 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 — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes Mellitus, Type 2 on oral agents
- •Age > 30 years
Exclusion Criteria
- •Severe Asthma, severe Chronic Obstructive Pulmonary Disease
Arms & Interventions
Insulin Glargine (Lantus®)
Active Comparator
Intervention: Insulin Glargine (Lantus®) (Drug)
Inhaled Human Insulin (Exubera®)
Active Comparator
Intervention: Inhaled Human Insulin (Exubera®) (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Time Frame: Baseline, Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
Secondary Outcomes
- Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)(Baseline, Week 26)
- Number of Subjects With Hypoglycemic Events by Severity(Week 26)
- Number of Events of Nocturnal Hypoglycemia(Week 26)
- Change From Baseline in Body Weight(Baseline, Week 26)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 26)
- Number of Subjects Discontinued Due to Insufficient Clinical Response(Week 26)
- Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients(Baseline, Week 26)
- Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)(Baseline, Week 26)
- Change From Baseline in HbA1c Prior to Week 26(Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18)
- Number of Subjects With HbA1c < 6.5 %(Week 26)
- Number of Subjects With HbA1c < 7.0 %(Week 26)
- Number of Subjects With HbA1c < 8.0 %(Week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG) Level(Baseline, Week 26)
Investigators
Study Sites (62)
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