Type 1 Diabetes MellitusNCT01201928
Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166
An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Mannkind Corporation at 14 sites in United States.
Trial summary
The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Comparator administered in parent trial and Technosphere Insulin Inhalation Powder
- How many people
- 3 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2010to Mar 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166
Who may be able to join
- Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166)
Who cannot join
- Subjects who are unable to perform PFTs that meet American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability and repeatability will be excluded from this study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Israel Hartman MD
Arlington, Texas, 76014
Laureate Clinical Research Group
Atlanta, Georgia, 30308
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Billings Clinic Research Center
Billings, Montana, 59101
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
Alta Pharmaceutical Research Center
Dunwoody, Georgia, 30338
Valley Research
Fresno, California, 93720
Endocrine Research Physicians East PA
Greenville, North Carolina, 27834
Health Care Partners Medical Group
Long Beach, California, 90806
LaPorte County Institute for Clinical Research Inc.
Michigan City, Indiana, 46360
Winthrop University Hospital
Mineola, New York, 11501
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042
SAM Clinical Research Center
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes
The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study.
Read the detailed description
This study is designed to evaluate and compare changes in pulmonary function (FEV1(forced expiratory volume in 1 second) FVC(forced vital capacity), TLC (total lung capacity) and DLco) in subjects enrolled in 1 of 3 parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166). Up to 100 subjects with Type I and Type II diabetes in the TI Inhalation Powder arm, and 100 subjects with Type I and Type II diabetes in the comparator arm will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent trial.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- Comparator administered in parent trial, 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.
Comparator administered in parent trialDrug
Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes
Technosphere Insulin Inhalation PowderDrug
Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)
| Study group | Role | What they receive |
|---|---|---|
| Technosphere Insulin Inhalation Powder | Not described Receives: Drug: Technosphere Insulin Inhalation Powder | |
| Comparator | Based on parent trial Receives: Drug: Comparator administered in parent trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models.
Measured: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2012
Why it stopped: Parent trials were either not initiated or terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 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
- NCT01201928
- Sponsor's protocol ID
- MKC-TI-164
- Status last verified
- Dec 2012
- First submitted
- 27 Aug 2010
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01201928
- Acronym / sponsor ID
- MKC-TI-164
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Parent trials were either not initiated or terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Sep 2010 (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 evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study.
Detailed description
This study is designed to evaluate and compare changes in pulmonary function (FEV1(forced expiratory volume in 1 second) FVC(forced vital capacity), TLC (total lung capacity) and DLco) in subjects enrolled in 1 of 3 parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166). Up to 100 subjects with Type I and Type II diabetes in the TI Inhalation Powder arm, and 100 subjects with Type I and Type II diabetes in the comparator arm will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technosphere Insulin Inhalation Powder | – | Drug: Technosphere Insulin Inhalation Powder |
| Comparator | – | Drug: Comparator administered in parent trialBased on parent trial |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166
Key inclusion criteria (1 listed)
- Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166)
Key exclusion criteria (1 listed)
- Subjects who are unable to perform PFTs that meet American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability and repeatability will be excluded from this study
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 |
|---|---|---|
| Comparator administered in parent trialComparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes | Drug | Comparator |
| Technosphere Insulin Inhalation PowderPulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial) | Drug | Technosphere Insulin Inhalation Powder |
Primary outcome
Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models.
Time frame: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).
Results and safety
The study was stopped early (reason given: Parent trials were either not initiated or terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Dec 2012. 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?
The study was stopped early (reason given: Parent trials were either not initiated or terminated). 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.
What does the primary outcome measure?
Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models. (time frame: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).). 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 6 Dec 2012.