Clinical trial NCT00356421: A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Official title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
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 Humalog in patients with type 1 diabetes mellitus

Detailed description: Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 1

Exclusion Criteria:

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
* Smoking

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
timeFrame: At 52 weeks
Secondary outcomes:
measure: Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%
timeFrame: At 52 weeks
measure: Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%
timeFrame: At 52 weeks
measure: Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline
timeFrame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.
measure: Change From Baseline in FPG
timeFrame: At 52 weeks or last observation
measure: Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments
timeFrame: To 52 weeks
measure: Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments
timeFrame: To 52 weeks
measure: Change From Baseline in Insulin Antibody Levels
timeFrame: At weeks 24 and 52 or last observation.
measure: Change From Baseline in Body Weight
timeFrame: At weeks 12, 24, 36, and 52 or last observation.
measure: Change From Baseline in Body Mass Index
timeFrame: At weeks 12, 24, 36, and 52 or last observation.
measure: Change From Baseline in Basal Insulin Doses
timeFrame: To 52 weeks
measure: Change From Baseline in Prandial Insulin Doses
timeFrame: To 52 weeks
measure: Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)
timeFrame: To 52 weeks.
measure: Change in Fasting Lipids From Baseline
timeFrame: At weeks 24 and 52 or last observation
Other outcomes:
measure: Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire
timeFrame: At weeks 6, 24, and 52 or last observation
measure: Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement
timeFrame: At weeks 6, 24, and 52 or last observation
Locations:
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Aarhus
country: Denmark
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Brest CEDEX
country: France
facility: Pfizer Investigational Site
city: Corbeil Essonnes Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Waterford
country: Ireland
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Las Palmas
country: Spain
facility: Pfizer Investigational Site
state: Las Palmas de Gran Canaria
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Bournemouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Dorset
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
state: Tayside
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: