Clinical trial NCT00391027: A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes, insulin, glycemic control
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-23
Enrollment: 261
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus, Type 2 on oral agents
* Age \> 30 years

Exclusion Criteria:

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease
* Smoking

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c Prior to Week 26
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18
measure: Number of Subjects With HbA1c < 6.5 %
timeFrame: Week 26
measure: Number of Subjects With HbA1c < 7.0 %
timeFrame: Week 26
measure: Number of Subjects With HbA1c < 8.0 %
timeFrame: Week 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Level
timeFrame: Baseline, Week 26
measure: Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
timeFrame: Baseline, Week 26
measure: Number of Subjects With Hypoglycemic Events by Severity
timeFrame: Week 26
measure: Number of Events of Nocturnal Hypoglycemia
timeFrame: Week 26
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 26
measure: Number of Subjects Discontinued Due to Insufficient Clinical Response
timeFrame: Week 26
measure: Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health
timeFrame: Week 26
measure: Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
timeFrame: Baseline, Week 26
measure: Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
timeFrame: Baseline, Week 26
measure: Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
timeFrame: Baseline, Week 26
measure: Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
timeFrame: Baseline, Week 26
measure: Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
timeFrame: Baseline, Week 26
measure: Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Bornem
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Liège 1
country: Belgium
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Corbeil Essonnes Cedex
country: France
facility: Pfizer Investigational Site
city: LA Rochelle CEDEX
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 5
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 10
country: France
facility: Pfizer Investigational Site
city: Valenciennes Cedex 1
country: France
facility: Pfizer Investigational Site
city: Altenburg
country: Germany
facility: Pfizer Investigational Site
city: Eisenach
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hohenmoelsen
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Neuss
country: Germany
facility: Pfizer Investigational Site
city: Riesa
country: Germany
facility: Pfizer Investigational Site
city: Wangen / Allgaeu
country: Germany
facility: Pfizer Investigational Site
city: Den Bosch
country: Netherlands
facility: Pfizer Investigational Site
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Venlo
country: Netherlands
facility: Pfizer Investigational Site
city: Honefoss
country: Norway
facility: Pfizer Investigational Site
state: Buskerud
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Jessheim
country: Norway
facility: Pfizer Investigational Site
city: Lysaker
country: Norway
facility: Pfizer Investigational Site
city: Skedsmokorset
country: Norway
facility: Pfizer Investigational Site
city: Lask
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: Inca
country: Spain
facility: Pfizer Investigational Site
state: Mallorca
city: La Laguna
country: Spain
facility: Pfizer Investigational Site
state: Santa Cruz de Tenerife
city: Alzira
country: Spain
facility: Pfizer Investigational Site
state: Valencia
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Huelva
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Eksjo
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Harnosand
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Järfälla
country: Sweden
facility: Pfizer Investigational Site
city: Kristianstad
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Motala
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uddevalla
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
city: Vaxjo
country: Sweden
facility: Pfizer Investigational Site
city: Bruderholz
country: Switzerland
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: