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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01021891

Enrollment

Registered

2009-11-30

Start date

2006-07-31

Completion date

2008-11-30

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Technosphere® Insulin Inhalation Powder

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).

Interventions

DRUGTechnosphere®/Insulin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I	30 days

Countries

Austria, Netherlands, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026