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 - Full Text View

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00662857

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 II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
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

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
1: Experimental 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

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:	MannKind Corporation ( Anders H. Boss, MD, MFPM )
Study ID Numbers:	MKC-TI-116
Study First Received:	April 16, 2008
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00662857 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:

Diabetic adult male, diabetic adult female

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009