- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00662857
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
A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Chula Vista, California, United States, 91911
- Profil Institute for Clinical Research Inc.
-
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Texas
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San Antonio, Texas, United States, 78229
- Diabetes & Glandular Disease Research Assoc PA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1: TI Inhalation Powder A
Technosphere® Insulin Inhalation Powder, two 15 U cartridges
|
TI Inhalation Powder, two 15 U cartridges
|
Experimental: 2: TI Inhalation Powder B
Technosphere® Insulin Inhalation Powder, one 30 U cartridge
|
TI Inhalation Powder, one 30 U cartridge
|
Experimental: 3: RAA Population
Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro
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RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360
Time Frame: 0 to 360 minutes post-dose
|
Dose-normalized baseline-corrected area under the serum insulin vs. time curve
|
0 to 360 minutes post-dose
|
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.
Time Frame: 0 to 360 minutes post-dose
|
Maximum observed baseline-corrected serum insulin concentration
|
0 to 360 minutes post-dose
|
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax
Time Frame: 0 to 360 minutes post-dose
|
0 to 360 minutes post-dose
|
|
Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro
Time Frame: 0 to 360 minutes post-dose
|
Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)
|
0 to 360 minutes post-dose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKC-TI-116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Technosphere® Insulin Inhalation Powder
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Mannkind CorporationCompletedDiabetes, Type 2 | Diabetes, Type 1United States, Spain, Canada, Russian Federation, Czech Republic, Poland, Ukraine, United Kingdom
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Mannkind CorporationCompleted
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Mannkind CorporationCompletedType 2 Diabetes MellitusUnited States, Czech Republic, Bulgaria, Germany
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Mannkind CorporationCompletedDiabetes Type 2United States
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Mannkind CorporationCompletedType 2 DiabetesUnited States, Russian Federation, Brazil, Ukraine
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Mannkind CorporationCompletedType 1 Diabetes | Type 2 DiabetesUnited States, Brazil, Canada, Russian Federation
-
Mannkind CorporationTerminated
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Mannkind CorporationCompletedType 1 Diabetes MellitusUnited States
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States