Type 1 DiabetesNCT01798914
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
A study testing Technosphere Insulin Inhalation Powder in people with Type 1 Diabetes and Type 2 Diabetes, run by Mannkind Corporation at 14 sites in United States.
Trial summary
The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Technosphere Insulin Inhalation Powder
- How many people
- Not given
- Where
- 14 sitesUnited States
- Study dates
- Oct 2008to May 2015
- Phase
- Expanded access
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
- Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption
Who cannot join
- Smoking in the previous 6 months
- History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
- Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
- PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted, TLC < 80% of predicted.
- Allergy to insulin
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Annapolis Internal Medicine LLC
Annapolis, Maryland, 21401
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Nallin Family Healthcare
Cumberland, Maryland, 21502
North Country Community Physicians
Glen Cove, New York, 11542
Great Neck Medical Group
Great Neck, New York, 11021
University of Miami Diabetes Research Institute
Miami, Florida, 33136
Endocrinology Associates
Montgomery, Alabama, 36106
Diabetes and Endocrine Consultants P.C.
Montgomery, Alabama, 36117
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042
Dr. Rife and Associates Family Medicine
Orland Park, Illinois, 60467
Center for Diabetes and Endocrinology
Portsmouth, New Hampshire, 03801
Endocrinology Associates Inc.
Roanoke, Virginia, 24016
Highland Clini-Endocrinology
Shreveport, Louisiana, 71105
Primary Care Wakefield
Wakefield, Rhode Island, 02879
About this study
Official title: Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder
The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.
Read the detailed description
A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Technosphere Insulin Inhalation Powder
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere Insulin Inhalation PowderDrug
Also called Afrezza Inhalation Powder
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startOct 2008
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798914
- Sponsor's protocol ID
- MKC-TI-139
- Status last verified
- Jan 2016
- First submitted
- 19 Feb 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder
- ClinicalTrials.gov ID
- NCT01798914
- Acronym / sponsor ID
- MKC-TI-139
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Feb 2013 (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 study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.
Detailed description
A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
- Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption
Key exclusion criteria (5 listed)
- Smoking in the previous 6 months
- History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
- Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
- PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted, TLC < 80% of predicted.
- Allergy to insulin
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 PowderAlso: Afrezza Inhalation PowderPatient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
14 sites 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 Powder in people with Type 1 Diabetes and Type 2 Diabetes, run by Mannkind Corporation at 14 sites 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 5 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
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.
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 20 Jan 2016.