Type 1 Diabetes MellitusPhase 3NCT00642616
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
A Phase 3 study testing Technosphere® Insulin in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Mannkind Corporation at 21 sites in 3 countries.
Trial summary
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Moderate Chronic Obstructive Pulmonary Disease
- What is being tested?
- Technosphere® Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Mar 2009to Nov 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthma
- Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
- Never smoked or former smokers (= 6 months since cessation)
- ≥18 years of age
- Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
- < 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period
Show all 19Show fewer
- Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months
- COPD
- Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
- Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
- ≥40 years of age
- Postbronchodilator FEV1/FVC ratio < 70%
- Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)
- Both
- Clinical diagnosis of Type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
- BMI of, < 39 kg/m2
- Urine cotinine level ≤ 100ng/dL
- Clinical diagnosis of obstructive lung disease
- HbA1C > 6.5% ≤ 11.5%
Who cannot join
- History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2
- Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2
- Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days
- Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
- Greater than 2 hospitalizations or ER or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness
- Use of Symlin® (pramlintide acetate) within the preceding 90 days
Show all 11Show fewer
- Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline
- Previous exposure to any inhaled insulin product
- Currently using an insulin delivery pump
- Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
- Severe complications of diabetes mellitus, in the opinion of the PI or sub-investigator, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; and/or vascular claudication
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States12 sites
Study site
Dallas, Texas, 75225
Study site
Dallas, Texas, 75231
Study site
Federal Way, Washington, 98003
Study site
Flint, Michigan, 48504
Study site
Greenville, South Carolina, 29615
Study site
Medford, Oregon, 97504
Study site
Mission Hills, California, 91345
Study site
Morehead City, North Carolina, 28557
Study site
Palm Harbor, Florida, 34684
Study site
San Diego, California, 92117
Study site
Spartanburg, South Carolina, 29302
Study site
Tacoma, Washington, 98405
Russia7 sites
Study site
Kemerovo, RU, 650066
Study site
Moscow, RU, 105120
Study site
Saint Petersburg, RU, 191015
Study site
Saint Petersburg, RU, 191119
Study site
Saint Petersburg, RU, 194354
Study site
Saint Petersburg, RU, 198013
Study site
Yaroslavl, RUS, 150002
About this study
Official title: A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months Treatment Period With a 2 Month Follow-up
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Moderate Chronic Obstructive Pulmonary Disease, Asthma
- Being tested
- Technosphere® Insulin, Usual Care
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere® InsulinDrug
Also called Afrezza
Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents
Usual CareDrug
Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin
| Study group | Role | What they receive |
|---|---|---|
| Technosphere® Insulin (Asthma) | Experimental | Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma Receives: Drug: Technosphere® Insulin |
| Usual Care (Asthma) | Active comparator | Usual anti diabetic care in Diabetic participants with Asthma Receives: Drug: Usual Care |
| Technosphere® Insulin (COPD) | Experimental | Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD) Receives: Drug: Technosphere® Insulin |
| Usual Care (COPD) | Active comparator | Usual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD) Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-bronchodilator FEV1 From Baseline to Week 52
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
Measured: 52 Weeks
Secondary outcomes (3)
Number of Participants With Asthma Exacerbation by Treatment Arm
Number of participants who experienced worsening of asthma symptoms
Measured: Baseline to Week 52
Number of Participants With COPD Exacerbation by Treatment Arm
Number of participants who experienced worsening of COPD symptoms
Measured: Baseline to Week 52
Change in HbA1C From Baseline to Week 52
Measured: Baseline, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startMar 2009
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Terminated upon recommendation of the Data Safety Monitoring Board (DSMB)
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642616
- Sponsor's protocol ID
- MKC-TI-134
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2008
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months Treatment Period With a 2 Month Follow-up
- ClinicalTrials.gov ID
- NCT00642616
- Acronym / sponsor ID
- MKC-TI-134
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Moderate Chronic Obstructive Pulmonary Disease, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated upon recommendation of the Data Safety Monitoring Board (DSMB)
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Technosphere® Insulin (Asthma) | Experimental | Drug: Technosphere® InsulinTechnosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma |
| Usual Care (Asthma) | Active comparator | Drug: Usual CareUsual anti diabetic care in Diabetic participants with Asthma |
| Technosphere® Insulin (COPD) | Experimental | Drug: Technosphere® InsulinTechnosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD) |
| Usual Care (COPD) | Active comparator | Drug: Usual CareUsual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Asthma
- Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
- Never smoked or former smokers (= 6 months since cessation)
- ≥18 years of age
- Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
Key exclusion criteria (11 listed)
- History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2
- Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2
- Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days
- Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
- Greater than 2 hospitalizations or ER or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness
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® InsulinAlso: AfrezzaTechnosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents | Drug | Technosphere® Insulin (Asthma), Technosphere® Insulin (COPD) |
| Usual CareType 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin | Drug | Usual Care (Asthma), Usual Care (COPD) |
Primary outcome
Change in Post-bronchodilator FEV1 From Baseline to Week 52
Time frame: 52 Weeks
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
3 secondary outcomes
Number of Participants With Asthma Exacerbation by Treatment Arm
Time frame: Baseline to Week 52
Number of Participants With COPD Exacerbation by Treatment Arm
Time frame: Baseline to Week 52
Change in HbA1C From Baseline to Week 52
Time frame: Baseline, week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- 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.
Chief Medical Officer study chair
Mannkind Corporation
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Technosphere® Insulin in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Mannkind Corporation at 21 sites in 3 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 19 inclusion and 11 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Russia, Ukraine. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Feb 2016). 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?
Change in Post-bronchodilator FEV1 From Baseline to Week 52 (time frame: 52 Weeks). 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 14 Apr 2017.