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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)

NCT ID: NCT01021891

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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).

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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Technosphere® Insulin Inhalation Powder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-Diabetic Subj. w/o COPD

Single dose, 30 units

Group Type EXPERIMENTAL

Technosphere®/Insulin

Intervention Type DRUG

Non-Diabetic Subj. with COPD

Single dose, 30 units

Group Type EXPERIMENTAL

Technosphere®/Insulin

Intervention Type DRUG

Interventions

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Technosphere®/Insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mannkind Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Boss, MD

Role: STUDY_CHAIR

MannKind Corp

Locations

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Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Site Status

Medical University Graz

Graz, Graz, Austria

Site Status

University Medical Centre Groningen

Zuidlaren, , Netherlands

Site Status

Medicines Evaluation Unit (MEU)

Manchester, England, United Kingdom

Site Status

ICON Development Solutions

Manchester, , United Kingdom

Site Status

Countries

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United States Austria Netherlands United Kingdom

Other Identifiers

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EudraCT Number: 2007-002818-19

Identifier Type: -

Identifier Source: secondary_id

MKC-TI-015

Identifier Type: -

Identifier Source: org_study_id