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)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021891
• Other study ID #: MKC-TI-015
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2009
• Last updated: December 13, 2013
• Start date: July 2006
• Est. completion date: November 2008

Study information

• Verified date: December 2013
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Technosphere®/Insulin

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Netherlands	University Medical Centre Groningen	Zuidlaren
United Kingdom	ICON Development Solutions	Manchester
United Kingdom	Medicines Evaluation Unit (MEU)	Manchester	England
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Countries where clinical trial is conducted

United States,  Austria,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I		30 days	No