Type 2 Diabetes MellitusPhase 2NCT00754624
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
A Phase 2 study testing Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler in people with Type 2 Diabetes Mellitus, run by Mannkind Corporation at 40 sites in 4 countries.
Trial summary
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 40 sitesin 4 countries
- Study dates
- May 2004to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Previous completion of PDC-INS-0008 or MKC-TI-005
- Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial
- Subjects must be able to understand English or have access to validated primary language trial documents
- Written informed consent
Who cannot join
- Drug or alcohol dependency
- Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)
- Known hypersensitivity to the trial drug or to drugs of similar chemical structures
- Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)
- Evidence of moderate or greater ketones in urine
- Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)
- Women who are pregnant
- Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
United States17 sites
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Diabetes Care & Information Center of New York
Flushing, New York, 11365
Endocrine Research - Physician's East PA
Greenville, North Carolina, 27834
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060
University of Miami School of Medicine
Miami, Florida, 33136
Alliance Medical Group of Greater Waterbury
Middlebury, Connecticut, 06762
International Diabetes Center
Minneapolis, Minnesota, 55416
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Oschner Clinic Foundation
New Orleans, Louisiana, 70121
Diabetes Team Associated
New York, New York, 10016
Soundview Research Associates
Norwalk, Connecticut, 06851
Texas Diabetes Institute
San Antonio, Texas, 78207
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229
Dorothy L & James E Frank Diabetes Research Institute
San Mateo, California, 94401
Sansum Medical Research Institute
Santa Barbara, California, 93105
Diabetes Care Center
Seattle, Washington, 98105
Czechia14 sites
Military Hospital in Brno
Brno, CZE, 636 00
Hospital of "Milosrdnych brain"
Brno, CZE, 639 00
Surgery of Diabetology (Brno)
Brno, 612 00
University Hospital in Brno
Brno-Bohunice, CZE, 625 00
Surgery of Diabetology
Mělník, CZE, 276 01
University Hospital of 3rd Faculty
Prague, CZE, 100 34
Surgery of Diabetology Petrovice
Prague, CZE, 109 00
Diabetologicka oridnace
Prague, CZE, 120 00
General Hospital in Prague and 1st Faculty of Medicine of
Prague, CZE, 120 00
Institute for Clinical and Exp Medicine
Prague, CZE, 140 21
Surgery of Diabetology Stodulky
Prague, CZE, 155 00
University Hospital Na Bulovce
Prague, CZE, 180 81
Surgery of Diabetology Slany
Slaný, CZE, 274 01
Surgery of Diabetology Zastavka
Zastavka, Brno, CZE, 664 84
Bulgaria8 sites
MBAL "Pleven"
Pleven, BGR, 5800
SBALENG-Sofia Institute of Endocrinology
Sofia, BGR, 1303
MBAL Alexandrovska Hospital
Sofia, BGR, 1431
Military Medical Academy
Sofia, BGR, 1431
Central Clinical Base
Sofia, BGR, 1606
II-nd MBAL
Sofia, Sofia, 1202
Military Medical Academy
Sofia, 1431
MBAL "Sweta Marina" - Varna
Varna, BGR, 5000
About this study
Official title: A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
Read the detailed description
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
- Medical subject headings
- 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 Powder and MedTone™ InhalerDrug
Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
| Study group | Role | What they receive |
|---|---|---|
| TI Inhalation Powder | Experimental | Technosphere® Insulin Inhalation Powder Receives: Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Rate of Change in FEV1 From Baseline to End of Study
Measured: Baseline to 48 months
Secondary outcomes (6)
Annual Rate of Change in FVC From Baseline to End of Study
Measured: Baseline to 48 months
Annual Rate of Change in DLCo From Baseline to End of Study
Measured: Baseline to 48 months
Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)
Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)
Measured: Baseline to last measurement on study drug (maximum of 48 months
Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)
Change from Baseline to last study measurement on treatment (maximum of 48 months)
Measured: Baseline to last study measurement on treatment (maximum of 48 months)
Change in Weight in kg From Baseline to End of Study
Baseline to last measurement on study drug (maximum of 48 months)
Measured: Baseline to last measurement on study drug (maximum of 48 months)
High Resolution Computerized Tomography Scans of the Chest
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, MD, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754624
- Sponsor's protocol ID
- MKC-TI-010
- Status last verified
- Oct 2014
- First submitted
- 16 Sep 2008
- Last updated
- 16 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00754624
- Acronym / sponsor ID
- MKC-TI-010
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
Detailed description
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TI Inhalation Powder | Experimental | Drug: Technosphere® Insulin Inhalation Powder and MedTone™ InhalerTechnosphere® Insulin Inhalation Powder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous completion of PDC-INS-0008 or MKC-TI-005
- Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial
- Subjects must be able to understand English or have access to validated primary language trial documents
- Written informed consent
Key exclusion criteria (8 listed)
- Drug or alcohol dependency
- Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)
- Known hypersensitivity to the trial drug or to drugs of similar chemical structures
- Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)
- Evidence of moderate or greater ketones in urine
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 Powder and MedTone™ InhalerInhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U | Drug | TI Inhalation Powder |
Primary outcome
Annual Rate of Change in FEV1 From Baseline to End of Study
Time frame: Baseline to 48 months
6 secondary outcomes
Annual Rate of Change in FVC From Baseline to End of Study
Time frame: Baseline to 48 months
Annual Rate of Change in DLCo From Baseline to End of Study
Time frame: Baseline to 48 months
Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)
Time frame: Baseline to last measurement on study drug (maximum of 48 months
Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)
Time frame: Baseline to last study measurement on treatment (maximum of 48 months)
Change in Weight in kg From Baseline to End of Study
Time frame: Baseline to last measurement on study drug (maximum of 48 months)
High Resolution Computerized Tomography Scans of the Chest
Time frame: End of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 director
Mannkind Corporation
40 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler in people with Type 2 Diabetes Mellitus, run by Mannkind Corporation at 40 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 4 inclusion and 8 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Czechia, Bulgaria, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annual Rate of Change in FEV1 From Baseline to End of Study (time frame: Baseline to 48 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 16 Oct 2014.