Diabetes Mellitus, Type 2Phase 2NCT00570687
A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
A Phase 2 study testing Technosphere Insulin in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 1 site in Germany.
Trial summary
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Technosphere Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving diabetes treatment with insulin for a minimum of 3 months
- Body Mass Index (BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2
- HbA1c ≤ 8.5% based upon results from a central laboratory
- Non-smoking Males and females ≥ 18 and ≤ 70 years of age
- A clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months
Who cannot join
- Total daily insulin requirement of ≥ 1.2 U/kg body weight
- Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks
- Two or more severe hypoglycemic episodes within 6 months of screening
- Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening
- Severe complications of diabetes
- Previous exposure to any inhaled insulin product
Show all 31Show fewer
- Currently using an insulin delivery pump
- Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial
- Any clinically important pulmonary disease, confirmed by documented history, pulmonary function testing, or radiologic findings
- Chronic use of systemic steroids
- Inability to perform PFT maneuvers to meet the recommended American Thoracic Society (ATS) standards of acceptability and repeatability
- Significant improvement in spirometry following bronchodilation
- Active respiratory infection
- Seizure disorder
- Significant cardiovascular dysfunction and/or history within 3 months of Screening
- Uncontrolled hypertension with a systolic blood pressure of >160 mm Hg and/or diastolic blood pressure > 95 mm Hg at screening, despite pharmacologic treatment
- Clinical nephrotic syndrome or renal dysfunction or disease
- Cancer (other than an excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms
- History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes
- Active infection eg, Human Immunodeficiency Virus (HIV), Hepatitis, or history of severe infection within 30 days of Screening
- Anemia
- A previous diagnosis of systemic autoimmune or collagen vascular disease requiring prior or current treatment with systemic corticosteroids, cytotoxic drugs or penicillamine
- Any concurrent illness, other than diabetes mellitus not controlled by a stable therapeutic regime
- Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
- Clinically significant abnormalities on screening laboratory evaluation
- Female subjects who are pregnant, lactating or planning to become pregnant during the clinical trial period
- Female subjects of childbearing potential (defined as pre-menopausal and not surgically sterilized or post-menopausal for less than 2 years) not practicing adequate birth control.
- Current drug or alcohol abuse, or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial
- Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial during this trial
- Unable and/or unlikely to comprehend and/or follow the trial protocol
- Concurrent medical or major psychiatric condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
Read the detailed description
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
After review of the meal challenge data from the Original Protocol design, it became apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and resulted in significantly higher insulin exposure following insulin lispro than the two inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled. However, the glucose clamp visits were discontinued since it was discovered that a direct comparison between the treatments was not possible.
The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1 due to the market removal of this product.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Technosphere Insulin
- Keywords
- Inhaled Insulin
- 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 InsulinDrug
Inhalation 15U/30U
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Technosphere Insulin Receives: Drug: Technosphere Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
Time to minimum EGP post dose
Measured: 0-480 minutes
Minimum EGP - Meal Challenge
Minimum calculated EGP per subject as change from baseline
Measured: 0-480 minutes
EGP AOC0-480 - Meal Challenge
EGP area over the curve from 0 to 480 minutes postdose
Measured: 0-480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
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 Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Rave, MD, Principal investigator, Profil Institute for Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570687
- Sponsor's protocol ID
- MKC-TI-118
- Status last verified
- Oct 2014
- First submitted
- 7 Dec 2007
- 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 Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00570687
- Acronym / sponsor ID
- MKC-TI-118
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Inhaled Insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Dec 2007 (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.
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
Detailed description
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
After review of the meal challenge data from the Original Protocol design, it became apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and resulted in significantly higher insulin exposure following insulin lispro than the two inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled. However, the glucose clamp visits were discontinued since it was discovered that a direct comparison between the treatments was not possible.
The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1 due to the market removal of this product.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Technosphere InsulinTechnosphere Insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receiving diabetes treatment with insulin for a minimum of 3 months
- Body Mass Index (BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2
- HbA1c ≤ 8.5% based upon results from a central laboratory
- Non-smoking Males and females ≥ 18 and ≤ 70 years of age
- A clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months
Key exclusion criteria (31 listed)
- Total daily insulin requirement of ≥ 1.2 U/kg body weight
- Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks
- Two or more severe hypoglycemic episodes within 6 months of screening
- Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening
- Severe complications of diabetes
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 InsulinInhalation 15U/30U | Drug | 1 |
Primary outcome
Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
Time frame: 0-480 minutes
Time to minimum EGP post dose
Minimum EGP - Meal Challenge
Time frame: 0-480 minutes
Minimum calculated EGP per subject as change from baseline
EGP AOC0-480 - Meal Challenge
Time frame: 0-480 minutes
EGP area over the curve from 0 to 480 minutes postdose
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.
Klaus Rave, MD principal investigator
Profil Institute for Metabolic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Technosphere Insulin in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 1 site in Germany.
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 5 inclusion and 31 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 1 site in 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?
Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge (time frame: 0-480 minutes). The study lists 3 primary outcomes in all. 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.