The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Initial dose of 1mg TID of inhaled human insulin
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Karachi, Sindh, Pakistan
Pfizer Investigational Site
Makati, Philippines
Pfizer Investigational Site
Marikina City, Philippines
Change in HbA1c From Baseline
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
Time frame: From baseline to week 16
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.
Time frame: 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.
Time frame: 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).
Time frame: up to week 4 or 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Pasay, Philippines
Pfizer Investigational Site
Pasig, Philippines
Pfizer Investigational Site
Quezon City, Philippines
Pfizer Investigational Site
Singapore, Singapore
Pfizer Investigational Site
Singapore, Singapore