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
Sponsor:
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

April 16, 2008
April 16, 2008
April 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Additional PK parameters of serum insulin and FDKP [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • 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
Experimental: 1
Technosphere Insulin Inhalation Powder
Interventions:
  • Drug: Technosphere Insulin A
  • Drug: Technosphere Insulin B
  • Drug: Humalog
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
28
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: MannKind Investigational Site 1-888-493-8622
Not Provided
 
NCT00662857
MKC-TI-116
Not Provided
Anders H. Boss, MD, MFPM, MannKind Corporation
Mannkind Corporation
Not Provided
Study Director: Anders H Boss, MD, MFPM Mannkind Corpotation
Mannkind Corporation
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP