A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356421
• Other study ID #: A2171035
• Status: Terminated
• Phase: Phase 4
• First received: July 24, 2006
• Last updated: August 25, 2009
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes mellitus Type 1

Exclusion Criteria:

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)

• Smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Inhaled Human Insulin (Exubera®)
Preprandial inhaled insulin regimen and administration of insulin glargine QD
• Insulin lispro (Humalog)
Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Vienna
Austria	Pfizer Investigational Site	Vienna
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Leuven
Denmark	Pfizer Investigational Site	Aarhus
Finland	Pfizer Investigational Site	Kuopio
France	Pfizer Investigational Site	Brest CEDEX
France	Pfizer Investigational Site	Corbeil Essonnes Cedex
France	Pfizer Investigational Site	Strasbourg Cedex
Ireland	Pfizer Investigational Site	Waterford
Netherlands	Pfizer Investigational Site	Amsterdam
Norway	Pfizer Investigational Site	Stavanger
Portugal	Pfizer Investigational Site	Lisboa
Spain	Pfizer Investigational Site	Las Palmas	Las Palmas de Gran Canaria
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Birmingham	West Midlands
United Kingdom	Pfizer Investigational Site	Bournemouth	Dorset
United Kingdom	Pfizer Investigational Site	Dundee	Tayside
United States	Pfizer Investigational Site	Hamilton	New Jersey
United States	Pfizer Investigational Site	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Denmark,  Finland,  France,  Ireland,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)		At 52 weeks	No
Secondary	Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%		At 52 weeks	No
Secondary	Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%		At 52 weeks	No
Secondary	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		At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.	No
Secondary	Change From Baseline in FPG		At 52 weeks or last observation	No
Secondary	Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments		To 52 weeks	No
Secondary	Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments		To 52 weeks	No
Secondary	Change From Baseline in Insulin Antibody Levels		At weeks 24 and 52 or last observation.	No
Secondary	Change From Baseline in Body Weight		At weeks 12, 24, 36, and 52 or last observation.	No
Secondary	Change From Baseline in Body Mass Index		At weeks 12, 24, 36, and 52 or last observation.	No
Secondary	Change From Baseline in Basal Insulin Doses		To 52 weeks	No
Secondary	Change From Baseline in Prandial Insulin Doses		To 52 weeks	No
Secondary	Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)		To 52 weeks.	No
Secondary	Change in Fasting Lipids From Baseline		At weeks 24 and 52 or last observation	No

External Links

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