Type 2 DiabetesPhase 3NCT01196104
Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
A Phase 3 study testing Technosphere® Insulin Inhalation Powder, Insulin Aspart and Insulin Glargine in people with Type 2 Diabetes, run by Mannkind Corporation at 29 sites in United States.
Trial summary
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Technosphere® Insulin Inhalation Powder, Insulin Aspart and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 29 sitesUnited States
- Study dates
- Sep 2010to Mar 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 and ≤ 80 years of age
- Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
- Body mass index (BMI) ≤ 45 kg/m2
- Glycated Hemoglobin (HbA1c) > 6.5% and ≤ 10.0%
- Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
- Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
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- Office spirometry at the investigator site
- Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
- Forced vital capacity (FVC) ≥ 65% NHANES III predicted
- Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)
Who cannot join
- Current or prior treatment with prandial or PreMix (70/30) insulin
- History of insulin pump use within 6 weeks of Visit 1
- Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
- History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
- Any clinically significant radiological findings on screening chest x-ray
- Use of medications for asthma, COPD, or any other chronic respiratory conditions
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- Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
- Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure [New York Heart Association {NYHA} Class III or IV])
- Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
- History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of New Mexico HCS
Albuquerque, New Mexico, 87131
Laureate Clinical Research Group
Atlanta, Georgia, 30308
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Billings Clinic Research Center
Billings, Montana, 59101
John H Stoger Jr Hospital of Cook County
Chicago, Illinois, 60612
Amin Radparvar's Private Practice
City of Saint Peters, Missouri, 63376
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
Baylor Endocrine Center
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Alta Pharmaceutical Research Center
Dunwoody, Georgia, 30338
Radiant Research Inc (Minneapolis)
Edina, Minnesota, 55435
Valley Research
Fresno, California, 93720
Endocrine Research Physicians East PA
Greenville, North Carolina, 27834
Health Care Partners Medical Group
Long Beach, California, 90806
Exodus Healthcare Network
Magna, Utah, 84044
The Endocrine Clinic
Memphis, Tennessee, 38119
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, 44060
LaPorte County Institute for Clinical Research Inc.
Michigan City, Indiana, 46360
Winthrop University Hospital
Mineola, New York, 11501
Coastal Clinical Research Inc
Mobile, Alabama, 36608
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042
Creighton Diabetes Center
Omaha, Nebraska, 68131
Legacy Clinical Research
Portland, Oregon, 97232
OHSU Diabetes Center Research Oregon Health & Science University
Portland, Oregon, 97239
SAM Clinical Research Center
San Antonio, Texas, 78229
Diabetes Research Center -Fletcher Allen Health Care
South Burlington, Vermont, 05403
Washington University School of Medicine
St Louis, Missouri, 63110
Diabetes Research Center
Tustin, California, 92780
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.
Read the detailed description
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- Technosphere® Insulin Inhalation Powder, Insulin Aspart, Insulin Glargine
- 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 PowderDrug
Insulin AspartDrug
Usual Care
Insulin GlargineDrug
| Study group | Role | What they receive |
|---|---|---|
| Technosphere® Insulin Inhalation Powder (TI) | Experimental | Insulin Glargine and Technosphere® Insulin Inhalation Powder Receives: Drug: Technosphere® Insulin Inhalation Powder; Drug: Insulin Glargine |
| Comparator | Active comparator | Insulin Glargine and Insulin Aspart Receives: Drug: Insulin Aspart; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%) From Baseline to Week 16
Change from Baseline in glycated hemoglobin at Week 16
Measured: Baseline to Week 16
Secondary outcomes (25)
To Evaluate the Effect of Each Treatment on HbA1c
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Glycomark and Fructosamine Levels Measured Throughout the Study
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Seven-point Glucose at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Changes in Body Weight at 16 Weeks
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires
Not analyzed due to early termination of the trial.
Measured: Change from baseline to 16 weeks
Total Number of Cough Episodes
Total number of times patients coughed once, intermittently or continuously (inclusive)
Measured: Baseline to Week 16
Severe Hypoglycemic Event Rate
Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation
Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:
- SMBG levels ≤ 36 mg/dL OR
- There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures
Measured: Baseline to Week 16
Mild or Moderate Hypoglycemic Event Rate
Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation
Nonsevere hypoglycemia is defined as a subject:
- SMBG levels < 70 mg/dL AND/OR
- Symptoms that are relieved by the self-administration of carbohydrates
Measured: Baseline to Week 16
Number of Subjects Reporting Cough Episodes
Number of Subjects Reporting Cough Episodes
Measured: Baseline to Week 16
Number of Subjects Reporting Intermittent Coughing Episodes
Number of subjects reporting Intermittent Coughing Episodes
Measured: Baseline to Week 16
Number of Single Coughing Episodes
Total number of times patients coughed only once
Measured: Baseline to Week 16
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Measured: Baseline to Week 16
Baseline Forced Expiratory Volume in 1 Second (FEV1)
Baseline FEV1
Measured: Baseline
Week 16 Forced Expiratory Volume in 1 Second
Week 16 FEV1
Measured: Week 16
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Week 16 Change from Baseline in FEV1
Measured: Baseline to Week 16
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment
Measured: Week 20 (Follow-up)
Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1
Measured: Baseline to Week 20
Baseline Forced Vital Capacity (FVC)
Baseline FVC
Measured: Baseline
Week 16 Forced Vital Capacity
Week 16 FVC
Measured: Week 16
Week 16 Change From Baseline Forced Vital Capacity
Week 16 Change from Baseline FVC
Measured: Baseline to Week 16
Week 20 (Follow-up) Forced Vital Capacity
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC
Measured: Week 20
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC
Measured: Baseline to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionMar 2012
Why it stopped: For Business Reasons
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT01196104
- Sponsor's protocol ID
- MKC-TI-162
- Status last verified
- Oct 2014
- First submitted
- 30 Aug 2010
- Last updated
- 30 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period
- ClinicalTrials.gov ID
- NCT01196104
- Acronym / sponsor ID
- MKC-TI-162
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For Business Reasons
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Posted 21 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.
Detailed description
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technosphere® Insulin Inhalation Powder (TI) | Experimental | Drug: Technosphere® Insulin Inhalation Powder, Drug: Insulin GlargineInsulin Glargine and Technosphere® Insulin Inhalation Powder |
| Comparator | Active comparator | Drug: Insulin Aspart, Drug: Insulin GlargineInsulin Glargine and Insulin Aspart |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women ≥ 18 and ≤ 80 years of age
- Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
- Body mass index (BMI) ≤ 45 kg/m2
- Glycated Hemoglobin (HbA1c) > 6.5% and ≤ 10.0%
- Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
Key exclusion criteria (10 listed)
- Current or prior treatment with prandial or PreMix (70/30) insulin
- History of insulin pump use within 6 weeks of Visit 1
- Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
- History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
- Any clinically significant radiological findings on screening chest x-ray
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 | Drug | Technosphere® Insulin Inhalation Powder (TI) |
| Insulin AspartUsual Care | Drug | Comparator |
| Insulin Glargine | Drug | Comparator, Technosphere® Insulin Inhalation Powder (TI) |
Primary outcome
Change in HbA1c (%) From Baseline to Week 16
Time frame: Baseline to Week 16
Change from Baseline in glycated hemoglobin at Week 16
25 secondary outcomes
To Evaluate the Effect of Each Treatment on HbA1c
Time frame: Change from baseline to 16 weeks
Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study
Time frame: Change from baseline to 16 weeks
Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study
Time frame: Change from baseline to 16 weeks
Glycomark and Fructosamine Levels Measured Throughout the Study
Time frame: Change from baseline to 16 weeks
Seven-point Glucose at Randomization and Throughout the Study
Time frame: Change from baseline to 16 weeks
Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)
Time frame: Change from baseline to 16 weeks
Changes in Body Weight at 16 Weeks
Time frame: Change from baseline to 16 weeks
Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires
Time frame: Change from baseline to 16 weeks
Total Number of Cough Episodes
Time frame: Baseline to Week 16
Severe Hypoglycemic Event Rate
Time frame: Baseline to Week 16
Mild or Moderate Hypoglycemic Event Rate
Time frame: Baseline to Week 16
Number of Subjects Reporting Cough Episodes
Time frame: Baseline to Week 16
Number of Subjects Reporting Intermittent Coughing Episodes
Time frame: Baseline to Week 16
Number of Single Coughing Episodes
Time frame: Baseline to Week 16
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Time frame: Baseline to Week 16
Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline
Week 16 Forced Expiratory Volume in 1 Second
Time frame: Week 16
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Time frame: Baseline to Week 16
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
Time frame: Week 20 (Follow-up)
Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second
Time frame: Baseline to Week 20
Baseline Forced Vital Capacity (FVC)
Time frame: Baseline
Week 16 Forced Vital Capacity
Time frame: Week 16
Week 16 Change From Baseline Forced Vital Capacity
Time frame: Baseline to Week 16
Week 20 (Follow-up) Forced Vital Capacity
Time frame: Week 20
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
Time frame: Baseline to Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Technosphere® Insulin Inhalation Powder, Insulin Aspart and Insulin Glargine in people with Type 2 Diabetes, run by Mannkind Corporation at 29 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 10 inclusion and 10 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 30 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 29 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.
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 21 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?
Change in HbA1c (%) From Baseline to Week 16 (time frame: Baseline to Week 16). 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 30 Oct 2014.