Diabetes Mellitus, Type 2Phase 2NCT00419302
To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.
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
This trial was designed to compare meal related inhalation of Technosphere/Insulin to subcutaneous regular insulin in patients with type 2 diabetes. 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
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Apr 2004
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes mellitus.
- Current regimen of intensified insulin therapy for at least 6 months.
- Body Mass Index less than 35 kg/m2.
- HbA1c less than or equal to 9%.
- Non-smoker for at least 2 years.
- If medications in addition to insulin are taken at screening, the patient must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three months.
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- Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced mid-expiratory flow rate 25 %-75 % (FEF25-75), slow vital capacity (SVC) as measured by spirometry, and single-breath carbon monoxide diffusing capacity corrected for hemoglobin and carboxyhemoglobin (DLco), all greater than or equal to 80 % of expected normal.
- Ability to perform PFT, without coughing within the first 5 seconds of test.
- Written informed consent.
Who cannot join
- Diabetes mellitus type 1.
- Current treatment (within the last 30 days) with oral antidiabetic agents.
- Regular pre-prandial doses of regular insulin of more than 30 IU.
- Intake of any drug or herbal preparation which, in the evaluation of the investigator, may interfere with the interpretation of trial results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (e.g. systemic steroids).
- History of hypersensitivity to the study drug or to drugs with similar chemical structures.
- Treatment with any other investigational drug within three months prior to enrollment in study.
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- Progressive fatal disease.
- History of malignancy within five years of study entry (other than basal cell epithelioma).
- History of drug or alcohol abuse.
- Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidence by creatinine > 1.5 for females or > 1.8 for males, retinopathy, or severe peripheral vascular disease).
- Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy).
- Myocardial infarction or stroke within the preceding six months.
- Positive hepatitis B (hepatitis B surface antigen) and/or hepatitis C (hepatitis C antibody) serology and/or positive HIV serology.
- History or presence of clinically significant cardiovascular, hepatic (as evidenced by ALT or AST > 3 times the normal reference range), gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the study medication.
- Anemia (hemoglobin levels less than 11 g/dL for females or 12 g/dL for males).
- Ongoing respiratory tract infection.
- Pregnancy, lactation, or intention to become pregnant.
- Sexually active women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermacide, intrauterine devices, or surgical sterilization).
- Regular alcohol intake greater than 14 units*/week, or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, 1/4 liter of beer or 1 glass wine or 1 measure of spirits).
- Investigator or site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- A lack of compliance (including the inability to maintain a minimum of 75 % compliance with study drug administration) or other reasons, which in the opinion of the Investigator preclude the participation of the subject in the study.
- Prior diagnosis of idiopathic pulmonary fibrosis, asbestosis, silicosis, sarcoidosis, histiocytosis X (Langerhans cells histiocytosis), farmer's lung, Wegener's granulomatosis, pneumoconiosis (coal miner's lung), desquamative interstitial pneumonia, alveolar proteinosis, Goodpasture's syndrome, bronchiolitis obliterans organizing pneumonia (BOOP), hypersensitivity pneumonitis, lymphangioleiomyomatosis, amyloidosis, lymphocytic interstitial pneumonitis, Churg-Strauss syndrome (allergic granulomatosis and angiitis).
- Current or chronic infection with tuberculosis, cytomegalovirus, aspergillus, blastomyces, cryptococcus, histoplasma, coccidioides, pneumocystis carinii, mycobacterium avium intracellulare, pseudomonas, actinomyces, nodcardia, mucor, candida.
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine.
- History of chronic obstructive pulmonary disease, reactive airway disease, bronchiectasis, bronchiolitis obliterans, chronic bronchitis, emphysema or asthma requiring hospitalization and/or chronic treatment with supplemental oxygen or inhaled or systemic beta adrenoreceptor agonists, steroids or corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
This trial was designed to compare meal related inhalation of Technosphere/Insulin to subcutaneous regular insulin in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Technosphere/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
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response to a meal challenge
Secondary outcomes (2)
Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Safety variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startOct 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 16 participants
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus Rave, Principal investigator, Profil Institute for Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419302
- Sponsor's protocol ID
- MKC-TI-03B
- Status last verified
- Oct 2009
- First submitted
- 4 Jan 2007
- Last updated
- 14 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00419302
- Acronym / sponsor ID
- MKC-TI-03B
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Apr 2004
- First posted
- 8 Jan 2007 (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.
This trial was designed to compare meal related inhalation of Technosphere/Insulin to subcutaneous regular insulin in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of type 2 diabetes mellitus.
- Current regimen of intensified insulin therapy for at least 6 months.
- Body Mass Index less than 35 kg/m2.
- HbA1c less than or equal to 9%.
- Non-smoker for at least 2 years.
Key exclusion criteria (25 listed)
- Diabetes mellitus type 1.
- Current treatment (within the last 30 days) with oral antidiabetic agents.
- Regular pre-prandial doses of regular insulin of more than 30 IU.
- Intake of any drug or herbal preparation which, in the evaluation of the investigator, may interfere with the interpretation of trial results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (e.g. systemic steroids).
- History of hypersensitivity to the study drug or to drugs with similar chemical structures.
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 | Drug | – |
Primary outcome
Glycemic response to a meal challenge
2 secondary outcomes
Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Safety variables
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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 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 9 inclusion and 25 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 14 Oct 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic response to a meal challenge. 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 Oct 2009.