| Trial ID: | L2905 |
| Source ID: | NCT00437489
|
| Associated Drug: |
Inhaled Human Insulin (Exubera)
|
| Title: |
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00437489/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Inhaled Human Insulin (Exubera)|DRUG: Inhaled Human Insulin (Exubera)
|
| Outcome Measures: |
Primary: Change in HbA1c From Baseline, Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16, From baseline to week 16 | Secondary: Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF), Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values., From baseline to week 16|Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia, Cumulative Number Subjects Who Experienced Hypoglycemia \& Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose \<3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms., week 16|Hypoglycemia Event Rate Per Month, Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16)., up to week 4 or 16
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06
|
| Completion Date: |
2007-12
|
| Results First Posted: |
2009-03-06
|
| Last Update Posted: |
2009-05-11
|
| Locations: |
Pfizer Investigational Site, Hong Kong, Hong Kong|Pfizer Investigational Site, Karachi, Sindh, 74600, Pakistan|Pfizer Investigational Site, Makati, 1218, Philippines|Pfizer Investigational Site, Marikina City, 1810, Philippines|Pfizer Investigational Site, Pasay City, 1300, Philippines|Pfizer Investigational Site, Pasig City, 1605, Philippines|Pfizer Investigational Site, Quezon City, 1102, Philippines|Pfizer Investigational Site, Singapore, 119074, Singapore|Pfizer Investigational Site, Singapore, 159964, Singapore
|
| URL: |
https://clinicaltrials.gov/show/NCT00437489
|
