Diabetes Mellitus Type I and Type II MedDRA version: 8.1 Level: LLT Classification code 10012601
Conditions
Interventions
Trade Name: Exubera®
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin Human
Current Sponsor code: CP-464-005
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial has been obtained by the enrolling physician 4. The subject is willing to provide information on at least one alternate contact person for study staff to contact regarding subjects whereabouts, should the subject be lost-to-follow- up over the course of the study 5. The subject 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Original Protocol: The primary objective of this study is to estimate the relative risk of a persistent decline in forced expiratory volume in one second (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. Amendment April 2008: Unless unanticipated large effects emerge, the study will be underpowered to address the primary endpoint. However, the study data will still provide important descriptive information. Assuming the primary and secondary endpoints are underpowered, the risk of each endpoint will be estimated (and have corresponding 95% confidence intervals provided) among subjects randomized to Exubera® and subjects randomized to non-Exubera®.;Secondary Objective: Original Protocol: 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 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.;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 v | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed