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

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

Sponsors

Lead sponsor: Mannkind Corporation

Source Mannkind Corporation
Brief Summary

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).

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.

Overall Status Completed
Start Date April 2008
Completion Date December 2008
Primary Completion Date November 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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 0 to 360 minutes post-dose
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. 0 to 360 minutes post-dose
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 0 to 360 minutes post-dose
Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro 0 to 360 minutes post-dose
Enrollment 29
Condition
Intervention

Intervention type: Drug

Intervention name: Technosphere® Insulin Inhalation Powder

Description: TI Inhalation Powder, two 15 U cartridges

Arm group label: 1: TI Inhalation Powder A

Intervention type: Drug

Intervention name: Technosphere Insulin® Inhalation Powder

Description: TI Inhalation Powder, one 30 U cartridge

Arm group label: 2: TI Inhalation Powder B

Intervention type: Drug

Intervention name: RAA Population

Description: RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Arm group label: 3: RAA Population

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility
Profil Institute for Clinical Research Inc. | Chula Vista, California, 91911, United States
Diabetes & Glandular Disease Research Assoc PA | San Antonio, Texas, 78229, United States
Location Countries

United States

Verification Date

October 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: 1: TI Inhalation Powder A

Arm group type: Experimental

Description: Technosphere® Insulin Inhalation Powder, two 15 U cartridges

Arm group label: 2: TI Inhalation Powder B

Arm group type: Experimental

Description: Technosphere® Insulin Inhalation Powder, one 30 U cartridge

Arm group label: 3: RAA Population

Arm group type: Experimental

Description: Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov