Type 2 Diabetes MellitusPhase 2NCT00511602
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
A Phase 2 study testing Technosphere Insulin in people with Type 2 Diabetes Mellitus, run by Mannkind Corporation.
Trial summary
Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Technosphere Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of T2 DM of >2 years and <12 years duration
- Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
- Stable regimen for >3 months of oral anti-diabetes medication prior to enrollment
- HbA1c >6.6% and <10.5%
- BMI <38 kg/m2
- 18-80 years of age
- Baseline FVC and FEV1 >80% and <120% of predicted normal as measured by spirometry
- Baseline DLCO >80% and <120% of predicted normal
Who cannot join
- Clinical diagnosis of type 1 diabetes mellitus
- Subjects currently using insulin therapy or at the time of screening
- Known hypersensitivity to the study drug or to drugs of similar chemical structures
- Fasting plasma glucose >270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
- History of severe or multiple allergies
- History of tobacco or nicotine test at screening
Show all 21Show fewer
- Severe complications of diabetes including history of blindness from or Stage III or IV diabetic retinopathy, history of renal failure requiring dialysis or transplantation, history of amputation of limbs or digits related to diabetic vasculopathy
- Treatment with another investigational drug within 3 months prior to study entry (and for the duration of the study)
- Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids, beta blockers, with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension, or hydrochlorothiazide (HCTZ) at doses >25 mg/day
- Recent loss (within the 2 months prior to screening) of >5% of body weight
- Evidence of moderate or greater ketones in urine or ketoacidosis at screening
- History of chronic obstructive pulmonary disease or history of other known chronic pulmonary disease such as reactive airway disease, chronic bronchitis, emphysema, or asthma
- Diagnosis of AIDS or ARC
- A major psychiatric disorder that would have precluded satisfactory participation in this study
- Subjects who had had a myocardial infarction or stroke within the preceding six months
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring heart disease graded as Class III or Class IV according to New York Heart Association criteria
- Prior treatment with, or participation in, a clinical study involving an inhaled insulin product
- History of malignancy within 5 years of study entry (other than basal cell carcinoma)
- Significant hepatic disease (as evidenced by ALT or AST >3 times the reference normal range or bilirubin >1.5 times the reference normal range)
- Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females), proteinuria as evidenced by greater than "small" by dipstick measurement or >2 grams in 24 hours, dialysis, or history of renal transplant
- History of previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
About this study
Official title: Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education
Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Technosphere Insulin, Technosphere Placebo
- 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
Technosphere Insulin Inhalation Powder
Technosphere PlaceboDrug
Technosphere Inhalation Powder
| Study group | Role | What they receive |
|---|---|---|
| Technosphere Insulin Inhalation Powder | Experimental | Not described Receives: Drug: Technosphere Insulin |
| Technosphere Inhalation Powder | Placebo comparator | Not described Receives: Drug: Technosphere Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline (week 2) to end of treatment (week 12)
Measured: 12 weeks
Secondary outcomes (7)
Area under the plasma glucose concentration versus time (AUCglucose)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Measured: every 4 weeks
Maximum glucose concentration (Cmax)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Measured: every 4 weeks
Time to maximum glucose concentration (tmax)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Measured: every 4 weeks
Area under the plasma glucose concentration versus time (AUCglucose)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Measured: every 4 weeks
Maximum glucose concentration (Cmax)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Measured: every 4 weeks
Time to maximum glucose concentration (tmax)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Measured: every 4 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Measured: every 2 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 startDec 2003
- Primary completionNov 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 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
- NCT00511602
- Sponsor's protocol ID
- PDC-INS-0008
- Status last verified
- Apr 2012
- First submitted
- 3 Aug 2007
- Last updated
- 30 Apr 2012
- Results posted
- No
Publications
Rosenstock J, Bergenstal R, Defronzo RA, Hirsch IB, Klonoff D, Boss AH, Kramer D, Petrucci R, Yu W, Levy B; 0008 Study Group. Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008 Nov;31(11):2177-82. doi: 10.2337/dc08-0315. Epub 2008 Aug 4.
PubMed 18678610
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education
- ClinicalTrials.gov ID
- NCT00511602
- Acronym / sponsor ID
- PDC-INS-0008
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 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.
Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technosphere Insulin Inhalation Powder | Experimental | Drug: Technosphere Insulin |
| Technosphere Inhalation Powder | Placebo comparator | Drug: Technosphere Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of T2 DM of >2 years and <12 years duration
- Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
- Stable regimen for >3 months of oral anti-diabetes medication prior to enrollment
- HbA1c >6.6% and <10.5%
- BMI <38 kg/m2
Key exclusion criteria (21 listed)
- Clinical diagnosis of type 1 diabetes mellitus
- Subjects currently using insulin therapy or at the time of screening
- Known hypersensitivity to the study drug or to drugs of similar chemical structures
- Fasting plasma glucose >270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
- History of severe or multiple allergies
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 InsulinTechnosphere Insulin Inhalation Powder | Drug | Technosphere Insulin Inhalation Powder |
| Technosphere PlaceboTechnosphere Inhalation Powder | Drug | Technosphere Inhalation Powder |
Primary outcome
HbA1c change from baseline (week 2) to end of treatment (week 12)
Time frame: 12 weeks
7 secondary outcomes
Area under the plasma glucose concentration versus time (AUCglucose)
Time frame: every 4 weeks
Maximum glucose concentration (Cmax)
Time frame: every 4 weeks
Time to maximum glucose concentration (tmax)
Time frame: every 4 weeks
Area under the plasma glucose concentration versus time (AUCglucose)
Time frame: every 4 weeks
Maximum glucose concentration (Cmax)
Time frame: every 4 weeks
Time to maximum glucose concentration (tmax)
Time frame: every 4 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time frame: every 2 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 30 Apr 2012.
- Derived from this study: PubMed 18678610Rosenstock J, Bergenstal R, Defronzo RA, Hirsch IB, Klonoff D, Boss AH, Kramer D, Petrucci R, Yu W, Levy B; 0008 Study Group. Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008 Nov;31(11):2177-82. doi: 10.2337/dc08-0315. Epub 2008 Aug 4.
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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 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 8 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 30 Apr 2012. 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. Some participants in this study may receive a placebo. 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?
HbA1c change from baseline (week 2) to end of treatment (week 12) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511602, which also lists 1 linked publication.
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 Apr 2012.