Type 2 Diabetes MellitusPhase 2NCT00511719
Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes
A Phase 2 study testing Technosphere Insulin and Actrapid in people with Type 2 Diabetes Mellitus, run by Mannkind Corporation.
Trial summary
The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere Insulin with those of subcutaneous (SC) regular human insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Technosphere Insulin and Actrapid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 2005
- 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 65 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 (defined as separate injections of basal and prandial insulin with at least three injections per day) for at least six months prior to the study, including the use of long-lasting insulin analogue glargine (Lantus)
- Patients must have been willing to withhold insulin glargine for 24 hours prior to study drug dosing
- 18 to 65 years old
- Body Mass Index <35kg/m2
- HbA1c<9%
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- Non-smoker for at least 2 years
- If medications (other than oral anti-diabetic agents) in addition to insulin were taken at screening, the patient had to be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least 3 months immediately prior to study enrollment
- FVC, FEV1, and VC all >80% of expected normal
- Written informed consent
Who cannot join
- Diabetes mellitus type 1
- Current treatment (within the last 30 days) with oral anti-diabetic agents
- Regular pre-prandial doses of regular subcutaneous insulin for more than 30 IU per meal
- Intake of any drug or herbal preparation that, in the evaluation of the investigator, may interfere with the interpretation of clinical trials results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (eg, systematic steroid)
- HIstory of hypersensitivity to the drug or to drugs with similar chemical structures
- Treatment with any investigation drug within 3 months prior to enrollment or during this study
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- Progressive fatal disease
- History of malignancy within 5 years of study entry (other than basal cell carcinoma)
- History of drug or alcohol abuse
- Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidenced by creatinine >1.5 mg/dL for females or >1.8 mg/dL for males, grade III or IV retinopathy, or severe peripheral vascular disease)
- Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy)
- Myocardial infraction 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 of 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 significant risk factor when taking the study medications
- Anemia (hemoglobin concentrations <11 g/dL for females of <g/dL for males)
- Ongoing respiratory tract infection
- Pregnancy, lactation, or intention to become pregnant
- Women of child-bearing potential practicing inadequate birth control (adequate birth control was defined as using oral contraceptives, condoms, or diaphragms with spermicide, intrauterine devices, or surgical sterilization)
- Regular alcohol intake greater than 14 units*/week, or patients unwilling to stop alcohol during the duration of the study (*1 unit=8 g ethanol, 1/4 liter of beer or 1 glass of wine or 1 measure of spirits)
- Investigator or site personnel directly affiliated with this study and their immediate families. Immediate family was defined as a spouse, parent, child or sibling, whether biological or legally adopted
About this study
Official title: A Prospective, Controlled, Single-Center, Open-Label,Randomized, Replicated, Crossover Isoglycemic Glucose Clamp Study Evaluating Intrapatient Variability in Bioavailability of Technosphere® Insulin Compared With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes
The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere Insulin with those of subcutaneous (SC) regular human insulin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Technosphere Insulin, Actrapid
- 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
48U
ActrapidDrug
24IU
| Study group | Role | What they receive |
|---|---|---|
| Technosphere Insulin | Experimental | Technosphere Insulin Inhalation Powder Receives: Drug: Technosphere Insulin |
| Actrapid | Active comparator | Subcutaneous regular human insulin Receives: Drug: Actrapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin
Measured: crossover approx every 2 weeks for up to 10 weeks
Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin
Measured: crossover approx every 2 weeks for up to 10 weeks
Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min)
Measured: crossover approx every 2 weeks for up to 10 weeks
Secondary outcomes (2)
Safety variables included adverse events, HbA1c, pulmonary function tests, and diabetes-specific signs (ie, hypoglycemia and hyperglycemia)
Measured: crossover approx every 2 weeks for up to 10 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, electrocardiograms, vital signs, physical examinations, and diabetes-specific signs
Measured: crossover approx every 2 weeks for up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startFeb 2004
- Primary completionApr 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511719
- Sponsor's protocol ID
- MKC-TI-003b2
- Status last verified
- Jun 2011
- First submitted
- 3 Aug 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Single-Center, Open-Label,Randomized, Replicated, Crossover Isoglycemic Glucose Clamp Study Evaluating Intrapatient Variability in Bioavailability of Technosphere® Insulin Compared With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00511719
- Acronym / sponsor ID
- MKC-TI-003b2
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Apr 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 6 Aug 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.
The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere Insulin with those of subcutaneous (SC) regular human insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technosphere Insulin | Experimental | Drug: Technosphere InsulinTechnosphere Insulin Inhalation Powder |
| Actrapid | Active comparator | Drug: ActrapidSubcutaneous regular human insulin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical Diagnosis of type 2 diabetes mellitus
- Current regimen of intensified insulin therapy (defined as separate injections of basal and prandial insulin with at least three injections per day) for at least six months prior to the study, including the use of long-lasting insulin analogue glargine (Lantus)
- Patients must have been willing to withhold insulin glargine for 24 hours prior to study drug dosing
- 18 to 65 years old
- Body Mass Index <35kg/m2
Key exclusion criteria (20 listed)
- Diabetes mellitus type 1
- Current treatment (within the last 30 days) with oral anti-diabetic agents
- Regular pre-prandial doses of regular subcutaneous insulin for more than 30 IU per meal
- Intake of any drug or herbal preparation that, in the evaluation of the investigator, may interfere with the interpretation of clinical trials results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (eg, systematic steroid)
- HIstory of hypersensitivity to the 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 Insulin48U | Drug | Technosphere Insulin |
| Actrapid24IU | Drug | Actrapid |
Primary outcome
Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin
Time frame: crossover approx every 2 weeks for up to 10 weeks
Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin
Time frame: crossover approx every 2 weeks for up to 10 weeks
Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min)
Time frame: crossover approx every 2 weeks for up to 10 weeks
2 secondary outcomes
Safety variables included adverse events, HbA1c, pulmonary function tests, and diabetes-specific signs (ie, hypoglycemia and hyperglycemia)
Time frame: crossover approx every 2 weeks for up to 10 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, electrocardiograms, vital signs, physical examinations, and diabetes-specific signs
Time frame: crossover approx every 2 weeks for up to 10 weeks
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 29 Jun 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Technosphere Insulin and Actrapid in people with Type 2 Diabetes Mellitus, run by Mannkind Corporation.
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 20 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin (time frame: crossover approx every 2 weeks for up to 10 weeks). 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 29 Jun 2011.