A Study to Evaluate Insulin in the Blood After Inhalation... | NCT01021891

Studies
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)

NCT01021891

Sponsor

Mannkind Corporation

Status

Completed

Last Update Posted

Dec 17, 2013Estimated

Enrollment

39Actual

Phase

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Technosphere®/Insulin

Countries

United States
Austria
Netherlands
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
EudraCT Number: 2007-002818-19

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 27, 2009

First Posted Date

Nov 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2013

Last Update Posted Date

Dec 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Diabetic Subj. w/o COPD	Experimental	Single dose, 30 units	Drug: Technosphere®/Insulin
Non-Diabetic Subj. with COPD	Experimental	Single dose, 30 units	Drug: Technosphere®/Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Technosphere®/Insulin	Drug		Non-Diabetic Subj. w/o COPD Non-Diabetic Subj. with COPD

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes & Glandular Disease Research Assoc PA		San Antonio	Texas	78229	United States
Medical University Graz

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms