Back to resultsA 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)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Technosphere®/Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Technosphere® Insulin Inhalation Powder
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Diabetes & Glandular Disease Research Assoc PA
- Medical University Graz
- University Medical Centre Groningen
- Medicines Evaluation Unit (MEU)
- ICON Development Solutions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-Diabetic Subj. w/o COPD
Non-Diabetic Subj. with COPD
Arm Description
Single dose, 30 units
Single dose, 30 units
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I
Full Information
NCT ID
NCT01021891
First Posted
November 25, 2009
Last Updated
December 13, 2013
Sponsor
Mannkind Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01021891
Brief Title
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)
Official Title
A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Trial objectives are to evaluate the impact of a defined lung disease (COPD) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects, 20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1 (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with T/I) and Visit 3 (follow up visit).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Technosphere® Insulin Inhalation Powder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Diabetic Subj. w/o COPD
Arm Type
Experimental
Arm Description
Single dose, 30 units
Arm Title
Non-Diabetic Subj. with COPD
Arm Type
Experimental
Arm Description
Single dose, 30 units
Intervention Type
Drug
Intervention Name(s)
Technosphere®/Insulin
Primary Outcome Measure Information:
Title
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Boss, MD
Organizational Affiliation
MannKind Corp
Official's Role
Study Chair
Facility Information:
Facility Name
Diabetes & Glandular Disease Research Assoc PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
University Medical Centre Groningen
City
Zuidlaren
ZIP/Postal Code
9470 AE
Country
Netherlands
Facility Name
Medicines Evaluation Unit (MEU)
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
ICON Development Solutions
City
Manchester
ZIP/Postal Code
M15 6SH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs