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A Study Designed to Compare 2 Dose Strengths 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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662857
First Posted: April 21, 2008
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mannkind Corporation
  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, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).

Condition Intervention Phase
Diabetes Mellitus: Type 1 Drug: Technosphere® Insulin Inhalation Powder Drug: Technosphere Insulin® Inhalation Powder Drug: RAA Population Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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:
  • Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360 [ Time Frame: 0 to 360 minutes post-dose ]
    Dose-normalized baseline-corrected area under the serum insulin vs. time curve

  • Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax. [ Time Frame: 0 to 360 minutes post-dose ]
    Maximum observed baseline-corrected serum insulin concentration

  • Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax [ Time Frame: 0 to 360 minutes post-dose ]
  • Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro [ Time Frame: 0 to 360 minutes post-dose ]
    Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)


Enrollment: 29
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: TI Inhalation Powder A
Technosphere® Insulin Inhalation Powder, two 15 U cartridges
Drug: Technosphere® Insulin Inhalation Powder
TI Inhalation Powder, two 15 U cartridges
Experimental: 2: TI Inhalation Powder B
Technosphere® Insulin Inhalation Powder, one 30 U cartridge
Drug: Technosphere Insulin® Inhalation Powder
TI Inhalation Powder, one 30 U cartridge
Experimental: 3: RAA Population
Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro
Drug: RAA Population
RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Detailed Description:
28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Males and Females > 18 and < 60 years of age 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662857


Locations
United States, California
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
United States, Texas
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mannkind Corporation
  More Information

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00662857     History of Changes
Other Study ID Numbers: MKC-TI-116
First Submitted: April 16, 2008
First Posted: April 21, 2008
Results First Submitted: July 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Mannkind Corporation:
Diabetic adult male, diabetic adult female

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
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