Diabetes Type 2Phase 2NCT00934414
Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes
A Phase 2 study testing Technosphere Insulin Inhalation Powder in people with Diabetes Type 2, run by Mannkind Corporation at 1 site in United States.
Trial summary
Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin in the body during a clamp procedure. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Technosphere Insulin Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Sep 2006
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non Smoking: Clinical diagnosis of type 2 diabetes mellitus.
- Non Smoking: Current basal and prandial insulin therapy for at least 6 weeks either alone or in combination with = 2 OHA
- Non Smoking: Negative urine cotinine test.
- Non Smoking: Non-smoker for at least 2 years.
- Smoking: Clinical diagnosis of type 2 diabetes mellitus.
- Smoking: Have been smoking for at least 5 years
Show all 24Show fewer
- Non Smoking: Body Mass Index (BMI) of = 40 kg/m2.
- Non Smoking: Glycosylated hemoglobin (HbA1c) of = 12%.
- Non Smoking: If other medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least 12 weeks immediately prior to trial enrollment.
- Non Smoking: Forced expiratory volume in one second / forced vital capacity (FEV1/FVC) of = NHANES III predicted Lower Limit of Normal.
- Non Smoking: FVC of = 80% NHANES III predicted value.
- Non Smoking: DLco of = 70% (uncorrected) Miller predicted value.
- Non Smoking: No upper respiratory infections within the last 15 days or lower respiratory infection within the last 30 days.
- Non Smoking: Must be of non-childbearing potential or using adequate birth control measures
- Smoking: Positive cotinine test.
- Smoking: Current basal and prandial insulin therapy for at least 6 weeks either alone or in combination with = oral antihyperglycemic agents.
- Smoking: BMI of = 40 kg/m2.
- Smoking: HbA1c of 12%.
- Smoking: If other medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least 12 weeks immediately prior to trial enrollment.
- Smoking: FEV1/FVC = NHANES III Predicted Lower Limit of Normal
- Smoking: FEV1 and FVC of = 60% NHANES III predicted value.
- Smoking: DLco = 70% of (uncorrected) of Miller predicted value.
- Smoking: No upper respiratory infections within the last 15 days or lower respiratory infection within the last 30 days.
- Smoking: Must be of non-childbearing potential or using adequate birth control measures.
Who cannot join
- Diabetes mellitus type 1.
- Total daily insulin requirement of = 1.4 U/kg.
- Intake of any drug or herbal preparation which, in the evaluation of the Investigator, may interfere with the clinical trial results by causing clinically relevant interference with glucose utilization, insulin action, or recovery from hypoglycemia (eg, systemic corticosteroids, oral or inhaled glucocorticosteroids).
- History of hypersensitivity to the trial drug or to drugs with similar chemical structures.
- Treatment with any investigational drug within 90 days prior to enrollment of trial.
- Progressive fatal disease.
Show all 21Show fewer
- History of malignancy within five years of trial entry (other than basal cell carcinoma).
- Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidenced by creatinine > 1.6 mg/dL for females or > 1.8 mg/dL for males, Stage III or IV retinopathy (according to the MKC diabetic retinopathy scale, see Appendix 1.1 of protocol), or severe peripheral vascular disease).
- Previous history of anaphylaxis or angioedema.
- Evidence of clinically significant autonomic neuropathy (gastroparesis, orthostatic hypotension or hypoglycemia unawareness).
- Myocardial infarction or stroke within the preceding six (6) months.
- Positive hepatitis B (HBsAg) or positive Human Immunodeficiency Virus (HIV) serology or active Hepatitis C (HepCAb) at screening.
- History or presence of clinically significant cardiovascular, hepatic, gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a significant risk factor when taking trial medication.
- ALT or AST > 3 times the upper limit of the normal reference range.
- Anemia (hemoglobin levels < 11 g/dL for females and < 12 g/dL for males).
- On-going respiratory infection.
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
- Pregnancy, lactation, or the intent of becoming pregnant during the trial period.
- Women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, or surgical sterilization).
- Current drug or alcohol abuse (regular alcohol intake > 14 units/week), or history which in the opinion of the investigator would not make the subject a suitable candidate for participation in this trial. A unit of alcohol is defined as 8 g of ethanol, ¼ liter of beer or 1 glass of wine or 1 measure of spirits.
- Investigator or site personnel directly affiliated with this trial, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research
Chula Vista, California, 91911
About this study
Official title: A Parallel, Controlled, Multi-Center, Single-Dose, One-Period Euglycemic Clamp Study Comparing Prandial Inhalation of Technosphere Insulin in Smokers and Non-Smokers With Type 2 Diabetes
Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin in the body during a clamp procedure.
Read the detailed description
MKC-TI-016 is a parallel, prospective, controlled, open-label, 1-period, single-dose trial utilizing a hyperinsulinemic-euglycemic clamp procedure to evaluate the bioavailability and bioeffect of inhaled TI Inhalation Powder in type 2 diabetic subjects who smoke compared to nonsmoking type 2 diabetic subjects.
- Conditions
- Diabetes Type 2
- Being tested
- Technosphere Insulin Inhalation Powder
- 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
30U
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Not described Receives: Drug: Technosphere Insulin Inhalation Powder |
| Non-Smokers | Experimental | Not described Receives: Drug: Technosphere Insulin Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability
Measured: 15 to 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startAug 2004
- Primary completionAug 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934414
- Sponsor's protocol ID
- MKC-TI-016
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Controlled, Multi-Center, Single-Dose, One-Period Euglycemic Clamp Study Comparing Prandial Inhalation of Technosphere Insulin in Smokers and Non-Smokers With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00934414
- Acronym / sponsor ID
- MKC-TI-016
- Conditions
- Diabetes Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 8 Jul 2009 (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.
Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin in the body during a clamp procedure.
Detailed description
MKC-TI-016 is a parallel, prospective, controlled, open-label, 1-period, single-dose trial utilizing a hyperinsulinemic-euglycemic clamp procedure to evaluate the bioavailability and bioeffect of inhaled TI Inhalation Powder in type 2 diabetic subjects who smoke compared to nonsmoking type 2 diabetic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Drug: Technosphere Insulin Inhalation Powder |
| Non-Smokers | Experimental | Drug: Technosphere Insulin Inhalation Powder |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Non Smoking: Clinical diagnosis of type 2 diabetes mellitus.
- Non Smoking: Current basal and prandial insulin therapy for at least 6 weeks either alone or in combination with = 2 OHA
- Non Smoking: Negative urine cotinine test.
- Non Smoking: Non-smoker for at least 2 years.
- Smoking: Clinical diagnosis of type 2 diabetes mellitus.
Key exclusion criteria (21 listed)
- Diabetes mellitus type 1.
- Total daily insulin requirement of = 1.4 U/kg.
- Intake of any drug or herbal preparation which, in the evaluation of the Investigator, may interfere with the clinical trial results by causing clinically relevant interference with glucose utilization, insulin action, or recovery from hypoglycemia (eg, systemic corticosteroids, oral or inhaled glucocorticosteroids).
- History of hypersensitivity to the trial drug or to drugs with similar chemical structures.
- Treatment with any investigational drug within 90 days prior to enrollment of trial.
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 Powder30U | Drug | Non-Smokers, Smokers |
Primary outcome
To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability
Time frame: 15 to 52 days
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 8 Jul 2009.
Related trials for Diabetes Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
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 Inhalation Powder in people with Diabetes Type 2, run by Mannkind Corporation at 1 site 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 24 inclusion and 21 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 8 Jul 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 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 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?
To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability (time frame: 15 to 52 days). 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 8 Jul 2009.