Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mannkind Corporation
Treatments:
Insulin
Insulin Lispro
Insulin, Globin Zinc
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