A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00391027
• Date of registration: 19/10/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
• Scientific title: 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
• Date of first enrolment: December 2006
• Target sample size: 261
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00391027
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Belgium, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Switzerland

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetes Mellitus, Type 2 on oral agents

- Age > 30 years

Exclusion Criteria:

- Severe Asthma, severe Chronic Obstructive Pulmonary Disease

- Smoking



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Inhaled Human Insulin (Exubera®)

Drug: Insulin Glargine (Lantus®)

Primary Outcome(s)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [Time Frame: Baseline, Week 26]

Secondary Outcome(s)

Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) [Time Frame: Baseline, Week 26]

Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) [Time Frame: Baseline, Week 26]

Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) [Time Frame: Baseline, Week 26]

Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (a) in a Subset of Subjects [Time Frame: Baseline, Week 26]

Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients [Time Frame: Baseline, Week 26]

Number of Subjects With Hypoglycemic Events by Severity [Time Frame: Week 26]

Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) [Time Frame: Baseline, Week 26]

Number of Subjects With HbA1c < 6.5 % [Time Frame: Week 26]

Change From Baseline in Body Mass Index (BMI) [Time Frame: Baseline, Week 26]

Number of Subjects With HbA1c < 8.0 % [Time Frame: Week 26]

Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health [Time Frame: Week 26]

Change From Baseline in Body Weight [Time Frame: Baseline, Week 26]

Number of Subjects Discontinued Due to Insufficient Clinical Response [Time Frame: Week 26]

Change From Baseline in Fasting Plasma Glucose (FPG) Level [Time Frame: Baseline, Week 26]

Change From Baseline in HbA1c Prior to Week 26 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18]

Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) [Time Frame: Baseline, Week 26]

Number of Subjects With HbA1c < 7.0 % [Time Frame: Week 26]

Number of Events of Nocturnal Hypoglycemia [Time Frame: Week 26]

Secondary ID(s)

A2171084

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/10/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00391027