DiabetesNCT01459133
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
A study testing Technosphere® Insulin Inhalation System in people with Diabetes, run by South Orange County Endocrinology at 1 site in United States.
Trial summary
The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Technosphere® Insulin Inhalation System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.
- Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.
Who cannot join
- Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.
- Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Orange County Endocrinology
Laguna Hills, California, 92653
About this study
Official title: Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.
Read the detailed description
This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.
INVESTIGATIONAL PRODUCT DESCRIPTION:
Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.
- Conditions
- Diabetes
- Being tested
- Technosphere® Insulin Inhalation System
- Keywords
- investigational, inhaled insulin product
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere® Insulin Inhalation SystemDrug
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
| Study group | Role | What they receive |
|---|---|---|
| Technosphere® Insulin Inhalation System | Experimental | Single Site, Single Subject use of Technosphere® Insulin Inhalation System Receives: Drug: Technosphere® Insulin Inhalation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.
Evaluate fasting plasma glucose and hemoglobin a1c
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startMay 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Orange County Endocrinology
- Sponsor type
- University, hospital or other
- Collaborators
- Mannkind Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459133
- Sponsor's protocol ID
- IND110021
- Status last verified
- Mar 2015
- First submitted
- 21 Oct 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
- ClinicalTrials.gov ID
- NCT01459133
- Acronym / sponsor ID
- IND110021
- Conditions
- Diabetes
- Keywords
- investigational, inhaled insulin product
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- South Orange County EndocrinologyUniversity, hospital or other
- Collaborators
- Mannkind Corporation
- Study start
- May 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 25 Oct 2011 (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.
The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.
Detailed description
This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.
INVESTIGATIONAL PRODUCT DESCRIPTION:
Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technosphere® Insulin Inhalation System | Experimental | Drug: Technosphere® Insulin Inhalation SystemSingle Site, Single Subject use of Technosphere® Insulin Inhalation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.
- Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.
Key exclusion criteria (2 listed)
- Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.
- Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.
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 Inhalation SystemSingle Site, Single Subject use of Technosphere® Insulin Inhalation System | Drug | Technosphere® Insulin Inhalation System |
Primary outcome
Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.
Time frame: 12-months
Evaluate fasting plasma glucose and hemoglobin a1c
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technosphere® Insulin Inhalation System in people with Diabetes, run by South Orange County Endocrinology at 1 site in United States.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone. (time frame: 12-months). 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 Mar 2015.