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

NCT ID: NCT00662857

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Diabetes Mellitus: Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: TI Inhalation Powder A

Technosphere® Insulin Inhalation Powder, two 15 U cartridges

Group Type: EXPERIMENTAL

Technosphere® Insulin Inhalation Powder

Intervention Type: DRUG

TI Inhalation Powder, two 15 U cartridges

2: TI Inhalation Powder B

Technosphere® Insulin Inhalation Powder, one 30 U cartridge

Group Type: EXPERIMENTAL

Technosphere Insulin® Inhalation Powder

Intervention Type: DRUG

TI Inhalation Powder, one 30 U cartridge

3: RAA Population

Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro

Group Type: EXPERIMENTAL

RAA Population

Intervention Type: DRUG

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

Interventions

Technosphere® Insulin Inhalation Powder

TI Inhalation Powder, two 15 U cartridges

Intervention Type: DRUG

Technosphere Insulin® Inhalation Powder

TI Inhalation Powder, one 30 U cartridge

Intervention Type: DRUG

RAA Population

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Profil Institute for Clinical Research Inc.

Chula Vista, California, United States

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MKC-TI-116

Identifier Type: -

Identifier Source: org_study_id