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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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)

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.

NCT01021891•Mannkind Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (5)

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Medical University Graz

Graz, Graz, Austria

University Medical Centre Groningen

Zuidlaren, Netherlands

Medicines Evaluation Unit (MEU)

Manchester, England, United Kingdom

ICON Development Solutions

Manchester, United Kingdom

Key Dates

Start Date

July 1, 2006

Primary Completion Date

August 1, 2008

Completion Date

November 1, 2008

Last Updated

December 17, 2013

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Technosphere®/Insulin

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A