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

NCT00662857 | Completed Phase 2 Results

• 1 other identifier: MKC-TI-116
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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).

Conditions

Diabetes Mellitus: Type 1

Keywords

Diabetic adult male, diabetic adult female

Outcome Measures

Primary Outcomes (4)

• 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

  Dose-normalized baseline-corrected area under the serum insulin vs. time curve

  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.

  Maximum observed baseline-corrected serum insulin concentration

  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

  Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)

  0 to 360 minutes post-dose

Study Arms (3)

1: TI Inhalation Powder A

EXPERIMENTAL

Technosphere® Insulin Inhalation Powder, two 15 U cartridges

Drug: Technosphere® Insulin Inhalation Powder

2: TI Inhalation Powder B

EXPERIMENTAL

Technosphere® Insulin Inhalation Powder, one 30 U cartridge

Drug: Technosphere Insulin® Inhalation Powder

3: RAA Population

EXPERIMENTAL

Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro

Drug: RAA Population

Interventions

Technosphere Insulin® Inhalation Powder DRUG

TI Inhalation Powder, one 30 U cartridge

2: TI Inhalation Powder B

RAA Population DRUG

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

3: RAA Population

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (2)

Profil Institute for Clinical Research Inc.

Chula Vista, California, 91911, United States

Location

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

US (2)