A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
Diabetes Mellitus: Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus: Type 1 focused on measuring Diabetic adult male, diabetic adult female
Eligibility Criteria
Inclusion Criteria:
Males and Females > 18 and < 60 years of age Clinical diagnosis of type 1 diabetes mellitus with stable anti-diabetic regimen for at least 90 days prior to Screening BMI of < 30 kg/m2 Non-smokers (never smoked or former smokers (> 6 months since cessation) Pulmonary Function Testing (FEV1 > 70%, FEV1/FVC > 70%, TLC > 80% DLco [unc] > 70% of Predicted Written Informed consent
Exclusion Criteria:
Two or more severe hypoglycemic episodes within 6 months of Screening/Visit 1 Severe complications of diabetes Previous exposure to any inhaled insulin product other than TI inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg. Obstructive sleep apnea), confirmed by pulmonary function testing, and/or radiologic findings Major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions
Sites / Locations
- Profil Institute for Clinical Research Inc.
- Diabetes & Glandular Disease Research Assoc PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
1: TI Inhalation Powder A
2: TI Inhalation Powder B
3: RAA Population
Technosphere® Insulin Inhalation Powder, two 15 U cartridges
Technosphere® Insulin Inhalation Powder, one 30 U cartridge
Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro