A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)

NCT01021891 | Completed Phase 1

• 2 other identifiers: MKC-TI-015EudraCT Number: 2007-002818-19
• Study Type: interventional
• Target: 39
• Locations: 4 countries
• Sites: 5

Brief Summary

Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Technosphere® Insulin Inhalation Powder

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP

  30 days

Secondary Outcomes (1)

• Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I

  30 days

Study Arms (2)

Non-Diabetic Subj. w/o COPD

EXPERIMENTAL

Single dose, 30 units

Drug: Technosphere®/Insulin

Non-Diabetic Subj. with COPD

EXPERIMENTAL

Single dose, 30 units

Drug: Technosphere®/Insulin

Interventions

Technosphere®/Insulin DRUG

Non-Diabetic Subj. w/o COPD; Non-Diabetic Subj. with COPD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects minimum 18 and maximum 70 years of age
• Body Mass Index (BMI) = 36 kg/m2
• Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis),
• smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion.
• Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III
• Predicted; FEV1/FVC \< 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller)
• Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of
• Predicted (ITS) and DLco(unc) =80% of Predicted (Miller)

You may not qualify if:

• History of pre-diabetes or diabetes
• Previous or current treatment with any anti-diabetic drugs
• Serum creatinine \> 2.0 mg/dL in males and \> 1.8 mg/dL in females
• Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months
• Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation
• Clinically significant major organ disease
• Female subjects of childbearing potential not practicing adequate birth control
• Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1);
• Any clinically important pulmonary disease except mild or moderate COPD
• Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (5)

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, 78229, United States

Location

Medical University Graz

Graz, Graz, A-8036, Austria

Location

University Medical Centre Groningen

Zuidlaren, 9470 AE, Netherlands

Location

Medicines Evaluation Unit (MEU)

Manchester, England, M23 9QZ, United Kingdom

Location

ICON Development Solutions

Manchester, M15 6SH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Boss, MD

  MannKind Corp

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: July 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

NL (1); US (1); GB (2); AU (1)