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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2006-001996-39-GB |
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Date of registration:
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21/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) |
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Date of first enrolment:
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15/12/2006 |
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Target sample size:
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5300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001996-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Usual diabetes care
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Germany
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus Type I and Type II
MedDRA version: 8.1
Level: LLT
Classification code 10012601
Term: Diabetes mellitus
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Intervention(s)
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Trade Name: EXUBERA®
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin Human
CAS Number: 11061-68-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: EXUBERA®
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin Human
CAS Number: 11061-68-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives are to compare subjects randomized to Exubera to those not randomized to Exubera to estimate the relative: (1) risk of pulmonary serious adverse event (SAE) composite, including: SAEs of for asthma, chronic obstructive pulmonary disease (COPD), pneumonia, or acute bronchitis, (2) risk of all-cause mortality, (3) risk of cardiovascular SAE composite, including: SAEs of cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke, (4) risk of allergic response SAE composite, including: SAEs of anaphylaxis, angioedema, generalized allergic reaction, and allergic bronchospasm, and (5) change in HbA1c from baseline at month 6, and years 1, 2, 3, 4 and 5.
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Main Objective: The primary objective of this study is to estimate the relative risk of a persistent decline in FEV1 exceeding 20% from baseline among subjects with diabetes randomized to Exubera as compared with those not randomized to Exubera. For both treatment groups, a persistent decline in FEV1 exceeding 20% from baseline is defined as an observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline in FEV1 exceeding 20% from baseline.
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Primary end point(s): For this study, all subjects are required to undergo spirometric tests to measure pulmonary function according to the approved local label; at baseline, 6 months, 1 year and then yearly thereafter for a total duration of 5 years. If during any follow-up visit known to the enrolling physician a FEV1 decline from baseline exceeding 20% is observed, a confirmatory spirometry test must be performed 3-4 weeks later. If the confirmatory spirometry verifies a decline in FEV1 from baseline exceeding 20%, Exubera therapy must be discontinued in subjects treated with Exubera (per the SmPC/USPI), and the subject should undergo another follow-up spirometry in 3 months.
A persistent decline in FEV1 exceeding 20% at the 3-month follow-up spirometry, deems the subject to have reached the primary endpoint (see Study Design Flowchart in Protocol Appendix 1.2.4). When a subject reaches the primary endpoint, he/she should be referred to a pulmonologist.
Several secondary endpoints will also be evaluated: (1) pulmonary serious adverse event (SAE) composite, including: SAEs of asthma, COPD, pneumonia, or acute bronchitis, (2) all-cause mortality, (3) cardiovascular SAE composite, including: SAEs of cardiovascular mortality, nonfatal myocardial infarction, or non-fatal stroke, (4) allergic response SAE composite, including: SAEs of anaphylaxis, angioedema, generalized allergic reaction, and allergic bronchospasm, and (5) change in HbA1c from baseline at month 6, and years 1, 2, 3, 4 and 5 (see Appendix 1.3).
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Secondary ID(s)
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Not Applicable
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2006-001996-39-DE
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A2171069
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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