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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662857

Contacts
Contact: MannKind Investigational Site 1-888-493-8622

Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Anders H Boss, MD, MFPM Mannkind Corpotation
  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
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014