AN INTERNATIONAL, MULTICENTER, LARGE SIMPLE TRIAL (LST) TO EVALUATE THE LONG-TERM PULMONARY AND CARDIOVASCULAR SAFETY OF EXUBERA® IN PATIENTS WITH DIABETES MELLITUS - Large Simple Trial (LST)
- Conditions
- Diabetes Mellitus Type I and Type IIMedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
- Registration Number
- EUCTR2006-001996-39-GB
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5300
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Eligible for receiving Exubera treatment based on the approved local label.
2. 18 years or older
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial has been obtained by the enrolling physician
4. The patient is willing to provide information on at least one alternate contact person for study staff to contact regarding patient’s whereabouts, should the patient be lost-to-follow- up over the course of the study
5. The patient is willing and able to comply with scheduled visits, pulmonary function
testing, and laboratory tests
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients presenting with any of the following will not be included in the study:
1. Pregnant or lactating
2. Have a progressive fatal disease or a life expectancy that prohibits them from
participating in a five-year research study
3. Have a medical or psychological condition that would prevent completion of a five-year study
4. Have participated in any other studies involving study drugs within 30 days prior to entry in the study
5. Previously enrolled in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method