Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01021891
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 1 study testing Technosphere®/Insulin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mannkind Corporation at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Technosphere®/Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jul 2006to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United Kingdom2 sites
Medicines Evaluation Unit (MEU)
Manchester, England, M23 9QZ
ICON Development Solutions
Manchester, M15 6SH
United States1 site
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229
About this study
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.
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.
Read the 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).
- Being tested
- Technosphere®/Insulin
- Keywords
- Technosphere® Insulin Inhalation Powder
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere®/InsulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Non-Diabetic Subj. w/o COPD | Experimental | Single dose, 30 units Receives: Drug: Technosphere®/Insulin |
| Non-Diabetic Subj. with COPD | Experimental | Single dose, 30 units Receives: Drug: Technosphere®/Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startJul 2006
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, MD, Study chair, MannKind Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021891
- Sponsor's protocol ID
- MKC-TI-015
- Other IDs
- EudraCT Number: 2007-002818-19
- Status last verified
- Dec 2013
- First submitted
- 25 Nov 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01021891
- Acronym / sponsor ID
- MKC-TI-015
- Keywords
- Technosphere® Insulin Inhalation Powder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Diabetic Subj. w/o COPD | Experimental | Drug: Technosphere®/InsulinSingle dose, 30 units |
| Non-Diabetic Subj. with COPD | Experimental | Drug: Technosphere®/InsulinSingle dose, 30 units |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technosphere®/Insulin | Drug | Non-Diabetic Subj. w/o COPD, Non-Diabetic Subj. with COPD |
Primary outcome
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
Time frame: 30 days
1 secondary outcome
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Boss, MD study chair
MannKind Corp
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technosphere®/Insulin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Mannkind Corporation at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.