HealthyPhase 1NCT00511979
Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin
A Phase 1 study testing Technosphere Insulin and Regular human insulin in people with Healthy, run by Mannkind Corporation.
Trial summary
A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Technosphere Insulin and Regular human insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Jun 2000
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be in good health, as judge by brief history and physical examination.
- Sex: both, male and female.
- Age: 18-40 years.
- Body mass index: 18-27 kg/m2.
- Capability to reach peak inspiratory flow of >41/sec measured by a computer assisted spirometry.
- FEV1 equal to or greater than 80% of predicted normal.
Who cannot join
- Diabetes Mellitus type 1 or type 2.
- Human insulin antibodies.
- Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.
- Having a history of severe or multiple allergies.
- Treatment with any other investigational drug in the last three months before study entry.
- Progressive fatal disease.
Show all 14Show fewer
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and /or hematological disease.
- Having ongoing respiratory tract infection.
- Smoker defined as subjects with evidence or history of tobacco or nicotine use in the last year prior to entry in the study.
- Blood donation within the last 30 days.
- A woman who is lactating.
- Pregnant women or women intending to become pregnant during the study.
- A sexually active woman of childbearing age not actively practicing birth control or using medically accepted device or therapy.
- A lack of compliance or other reasons, which prevent to the opinion of the investigator the participation of the subject in the study.
About this study
Official title: Effect of Different Doses of Inhaled Technosphere Insulin on Glucose Infusion Rates During Euglycemic Clamps in Comparison to a Subcutaneous Injection of Regular Human Insulin
A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.
- Conditions
- Healthy
- Being tested
- Technosphere Insulin, Regular human insulin
- Keywords
- Healthy Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere InsulinDrug
Technosphere insulinDrug
Technosphere insulinDrug
Regular human insulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Technosphere insulin inhalation system, 25 units | Experimental | Not described Receives: Drug: Technosphere Insulin |
| Technosphere insulin inhalation system, 50 units | Experimental | Not described Receives: Drug: Technosphere insulin |
| Technosphere insulin inhalation system, 100 units | Experimental | Not described Receives: Drug: Technosphere insulin |
| Subcutaneous regular human insulin | Active comparator | Not described Receives: Drug: Regular human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
Measured: crossover every 3-28 days for up to 20 weeks
Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
Measured: crossover every 3-28 days for up to 20 weeks
Secondary outcomes (1)
Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia)
Measured: crossover every 3-28 days for up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startAug 1999
- Primary completionFeb 2000
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511979
- Sponsor's protocol ID
- PDC-INS-0002
- Status last verified
- Jun 2012
- First submitted
- 3 Aug 2007
- Last updated
- 26 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Inhaled Technosphere Insulin on Glucose Infusion Rates During Euglycemic Clamps in Comparison to a Subcutaneous Injection of Regular Human Insulin
- ClinicalTrials.gov ID
- NCT00511979
- Acronym / sponsor ID
- PDC-INS-0002
- Conditions
- Healthy
- Keywords
- Healthy Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Feb 2000 (actual)
- Study completion
- Jun 2000 (actual)
- First posted
- 6 Aug 2007 (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.
A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Technosphere insulin inhalation system, 25 units | Experimental | Drug: Technosphere Insulin |
| Technosphere insulin inhalation system, 50 units | Experimental | Drug: Technosphere insulin |
| Technosphere insulin inhalation system, 100 units | Experimental | Drug: Technosphere insulin |
| Subcutaneous regular human insulin | Active comparator | Drug: Regular human insulin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be in good health, as judge by brief history and physical examination.
- Sex: both, male and female.
- Age: 18-40 years.
- Body mass index: 18-27 kg/m2.
- Capability to reach peak inspiratory flow of >41/sec measured by a computer assisted spirometry.
Key exclusion criteria (14 listed)
- Diabetes Mellitus type 1 or type 2.
- Human insulin antibodies.
- Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.
- Having a history of severe or multiple allergies.
- Treatment with any other investigational drug in the last three months before study entry.
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 | Technosphere insulin inhalation system, 25 units |
| Technosphere insulin | Drug | Technosphere insulin inhalation system, 50 units |
| Technosphere insulin | Drug | Technosphere insulin inhalation system, 100 units |
| Regular human insulin | Drug | Subcutaneous regular human insulin |
Primary outcome
Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
Time frame: crossover every 3-28 days for up to 20 weeks
Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
Time frame: crossover every 3-28 days for up to 20 weeks
1 secondary outcome
Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia)
Time frame: crossover every 3-28 days for up to 20 weeks
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 26 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technosphere Insulin and Regular human insulin in people with Healthy, run by Mannkind Corporation.
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 6 inclusion and 14 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment (time frame: crossover every 3-28 days for up to 20 weeks). The study lists 2 primary outcomes in all. 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 26 Jun 2012.