A Study Designed to Compare 2 Formulations 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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Mannkind Corporation.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Mannkind Corporation
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00662857
First received: April 16, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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Purpose
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, will be either two 15U cartridges or one 30U cartridge. Visit 4 dosing will be a sc injection of 10IU of RAA.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: Technosphere Insulin A Drug: Technosphere Insulin B Drug: Humalog |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Mannkind Corporation:
Primary Outcome Measures:
- Insulin AUC0-360min for TIB and TIA (assessment of bioequivalence) Insulin AUC0-360min for TIB to RAA (assessment of relative bioavailability) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Additional PK parameters of serum insulin and FDKP [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | July 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Technosphere Insulin Inhalation Powder
|
Drug: Technosphere Insulin A
Inhalation Powder, two 15U cartridges
Drug: Technosphere Insulin B
Inhalation Powder, one 30U cartridge
Drug: Humalog
A single subcutaneous 10IU of Rapid Acting Analogue
|
Detailed Description:
28 eligible subjects will be enrolled to determine bioequivalence and safety parameters of two 15U TI Inhalation Powder cartridges (TIA) vs. one 30U TI Inhalation Powder cartridge (TIB), according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30U TI Inhalation Powder cartridge to a single subcutaneous injection of 10IU of RAA will be compared.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Anders H. Boss, MD, MFPM, MannKind Corporation |
| ClinicalTrials.gov Identifier: | NCT00662857 History of Changes |
| Other Study ID Numbers: | MKC-TI-116 |
| Study First Received: | April 16, 2008 |
| Last Updated: | April 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mannkind Corporation:
|
Diabetic adult male, diabetic adult female |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Respiratory Aspiration Diabetes Mellitus Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin LISPRO Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013