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:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00662857
First received: April 16, 2008
Last updated: October 9, 2014
Last verified: October 2014

April 16, 2008
October 9, 2014
April 2008
November 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)
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 ]
Complete list of historical versions of study NCT00662857 on ClinicalTrials.gov Archive Site
Not Provided
Additional PK parameters of serum insulin and FDKP [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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, 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).

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.

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 Inhalation Powder
    TI Inhalation Powder, two 15 U cartridges
  • Drug: Technosphere Insulin® Inhalation Powder
    TI Inhalation Powder, one 30 U cartridge
  • Drug: RAA Population
    RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
  • Experimental: 1: TI Inhalation Powder A
    Technosphere® Insulin Inhalation Powder, two 15 U cartridges
    Intervention: Drug: Technosphere® Insulin Inhalation Powder
  • Experimental: 2: TI Inhalation Powder B
    Technosphere® Insulin Inhalation Powder, one 30 U cartridge
    Intervention: Drug: Technosphere Insulin® Inhalation Powder
  • Experimental: 3: RAA Population
    Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro
    Intervention: Drug: RAA Population
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2008
November 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662857
MKC-TI-116
Not Provided
Mannkind Corporation
Mannkind Corporation
Not Provided
Not Provided
Mannkind Corporation
October 2014

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