Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

Phase 3

Completed

Brief Summary: To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Recruitment & Eligibility

Inclusion Criteria

Clinical diagnosis of type 1 diabetes for at least 1 year
Nonsmokers for prior 6 months
BMI less than or equal to 35kg/m2
HbA1c > or = 7% and < or = 11%
Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
Urine cotinine < or = 100 ng/mL

Exclusion Criteria

History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
Evidence of severe complications of diabetes
Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Arm && Interventions

Group	Intervention	Description
1	Technosphere Insulin	Technosphere Insulin
2	Active comparator	Rapid-acting analogue insulin plus basal insulin glargine

Primary Outcome Measures

Name	Time	Method
Compare the Mean Change From Baseline to Week 52 in HbA1c	Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Weight to Week 52	Baseline to Week 52	Change from baseline in weight at Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52	Baseline to Week 52	Change from baseline in fasting plasma glucose at Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%	Baseline to Week 52	Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%
Incidence of Total Hypoglycemia	Baseline to Week 52	Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.
Incidence of Severe Hypoglycemia	Baseline to Week 52	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.
Total Hypoglycemia Event Rate	Baseline to Week 52	Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Severe Hypoglycemia Event Rate	Baseline to Week 52	Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

Locations (127): Coastal Clinical Research Inc
🇺🇸
Mobile, Alabama, United States
Radiant Research (Phoenix)
🇺🇸
Chandler, Arizona, United States
International Clinical Research Network
🇺🇸
Chula Vista, California, United States
Family Medical Center
🇺🇸
Foothill Ranch, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸
Huntington Beach, California, United States
South Bay Clinical Research
🇺🇸
Inglewood, California, United States
Radiant Research
🇺🇸
San Diego, California, United States
Coastal Biomedical Research Inc
🇺🇸
Santa Monica, California, United States
Diabetes Research Center
🇺🇸
Tustin, California, United States
International Research Associates LLC
🇺🇸
Miami, Florida, United States
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Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States