The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
677
Inhalation, 15U/30U
BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
Change From Baseline in HbA1c to Week 52
Time frame: Baseline to Week 52
Change From Baseline in Weight to Week 52
Time frame: Baseline to Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52
Time frame: Baseline to Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
Time frame: Week 52
Incidence of Total Hypoglycemia
Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.
Time frame: 52 Weeks
Incidence of Severe Hypoglycemia
Severe hypoglycemia occurs when all 3 of the following occur simultaneously: * Subject requires the assistance of another person; * Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); * Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, * Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.
Time frame: 52 Weeks
Total Hypoglycemia Event Rate
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Time frame: 52 Weeks
Severe Hypoglycemia Event Rate
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coastal Clinical Research Inc
Mobile, Alabama, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Southern Arizona VA Healthcare System
Tucson, Arizona, United States
Tucson Clinical Research
Tucson, Arizona, United States
International Clinical Research Network
Chula Vista, California, United States
Saad Hijazi MD Inc
Fresno, California, United States
Valley Research
Fresno, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
South Bay Clinical Research
Inglewood, California, United States
Southern California Endocrine Center
Pasadena, California, United States
...and 141 more locations
Time frame: 52 Weeks