A Clinical Trial Comparing Efficacy and Safety of Exubera and Humalog

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Inhaled Human Insulin (Exubera) (Drug); Insulin lispro (Humalog) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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 design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Change of glycosylated hemoglobin from baseline

Secondary outcome:

Change in glycosylated hemoglobin from baseline

Incidence of Hypoglycemia from baseline

Change in lipids from baseline

Change in insulin antibody titers from baseline

Change in glucose disposition from baseline

Change in diurnal glycemic excursions from baseline

Change in quality of life from baseline

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diabetes mellitus Type 1

Exclusion Criteria:

- Severe Asthma, severe COPD

- Smoking

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Vienna A-1130, Austria; Active, not recruiting

Pfizer Investigational Site, Wien A-1030, Austria; Active, not recruiting

Pfizer Investigational Site, Edegem 2650, Belgium; Active, not recruiting

Pfizer Investigational Site, Leuven 3000, Belgium; Active, not recruiting

Pfizer Investigational Site, Genk 3600, Belgium; Active, not recruiting

Pfizer Investigational Site, Aarhus 8000, Denmark; Recruiting

Pfizer Investigational Site, Kuopio 70211, Finland; Active, not recruiting

Pfizer Investigational Site, Corbeil Essonnes Cedex 91106, France; Recruiting

Pfizer Investigational Site, Brest CEDEX 29609, France; Active, not recruiting

Pfizer Investigational Site, Strasbourg Cedex 67091, France; Active, not recruiting

Pfizer Investigational Site, Waterford, Ireland; Active, not recruiting

Pfizer Investigational Site, Amsterdam NL-1105 AZ, Netherlands; Active, not recruiting

Pfizer Investigational Site, Stavanger 4095, Norway; Active, not recruiting

Pfizer Investigational Site, Lisboa 1349-019, Portugal; Recruiting

Pfizer Investigational Site, VALENCIA 46010, Spain; Active, not recruiting

Pfizer Investigational Site, Stockholm 182 88, Sweden; Active, not recruiting

Pfizer Investigational Site, Stockholm 171 76, Sweden; Active, not recruiting

Pfizer Investigational Site, Bournemouth, Dorset BH7 7DW, United Kingdom; Completed

Pfizer Investigational Site, LAS PALMAS, Las Palmas De Gran Canaria 35016, Spain; Active, not recruiting

Pfizer Investigational Site, New Brunswick, New Jersey 08903, United States; Recruiting

Pfizer Investigational Site, Hamilton, New Jersey 08610, United States; Recruiting

Pfizer Investigational Site, Dundee, Tayside DD1 9SY, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Birmingham, West Midlands B9 5SS, United Kingdom; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Ending date: January 2009
Last updated: May 12, 2008