- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544881
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
A Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Study in Subjects With Type 1 Diabetes Comparing Insulin Exposure & Response Following Inhalation of Technosphere Insulin Inhalation Powder Using the Gen2C Inhaler Vs Subcutaneous Rapid-Acting Analog
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects with Type 1 diabetes will be randomized to either one dose of TI inhaled using the Gen2C device, or one dose of subcutaneously injected Rapid Acting Analog (RAA) and crossed over.
Crossover Sequences:
Sequence #1: Period 1 - one 20 U cartridge of TI; Period 2 - 8 U of RAA
Sequence #2: Period 1 - 8 U RAA; Period 2 - one 20 U cartridge of TI
An euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to characterize the pharmacokinetics (PK) of the one dose of TI Inhalation Powder using the Gen2C inhaler as compared to one dose of subcutaneous RAA.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Chula Vista, California, United States, 91911
- Profil Institute for Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 18 to 60 years
- One of more daily sc insulin injections of any insulin type or insulin pump use
- Body mass index (BMI) = 30 kg/m2
Pulmonary function tests (PFTs) conducted at Visit 1:
- FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- FVC ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- Diagnosis of type 1 diabetes for at least 12 months
- Good venous access for blood draws
- Written informed consent provided
- No smoking in the previous 6 months (including cigarette, cigars, pipes) and negative urine cotinine testing (<100 ng/mL)
- C-peptide < 0.3 ng/mL
- Hemoglobin A1c (HbA1c) = 10.0%
Exclusion Criteria:
- Total daily insulin requirement of = 1.4 U/kg body weight
- Serum creatinine = 2.0 mg/dL in men and > 1.8 mg/dL in women
- Blood donation of 500 mL within the previous 56 days
- Current treatment with pramlintide acetate or exenatide
- Unstable diabetes control and evidence of severe complications of diabetes (ie, autonomic neuropathy)
- History of chronic obstructive pulmonary disease (COPD) or asthma, or any other clinically important pulmonary disease confirmed by pulmonary function testing or radiologic findings
- Upper respiratory tract infection within 8 weeks before screening
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Allergy to study drug, food, or other study material (eg, peanuts, soy products)
- Clinically significant active or chronic illness
- History of drug or alcohol abuse
- Positive urine drug screen
- Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
- Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin)
- History of malignancy within the 5 years before screening (other than basal cell carcinoma)
- History of human immunodeficiency virus (HIV) infection or hepatitis B or C
- Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
- Women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile
- Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder
- Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TI Inhalation Powder
Technosphere Insulin Inhalation Powder using the Gen2C inhaler
|
Inhalation Powder using the Gen2C inhaler
Other Names:
|
Active Comparator: RAA
Rapid Acting Analog
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Subcutaneous Injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing
Time Frame: Crossover 1 time within 3 - 10 days
|
Crossover 1 time within 3 - 10 days
|
PK measures for RAA (8U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing
Time Frame: Crossover 1 time within 3 - 10 days
|
Crossover 1 time within 3 - 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety variables including adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time Frame: Crossover 1 time within 3 - 10 days
|
Crossover 1 time within 3 - 10 days
|
Area under serum glucose infusion rate (GIR AUC 0-360) for TI Inhalation Powder (20U) as measured by: GIR AUC 0-360 timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing
Time Frame: Crossover 1 time within 3 - 10 days
|
Crossover 1 time within 3 - 10 days
|
Area under serum glucose infusion rate (GIR AUC 0-360) for RAA (8U) as measured by: GIR AUC 0-360 timepoints: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing
Time Frame: Crossover 1 time within 3 - 10 days
|
Crossover 1 time within 3 - 10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Chief Medical Officer, Mannkind Corporation
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-177
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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