Type 2 Diabetes MellitusPhase 2NCT00511732
18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of 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
Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled 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
- 227 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Aug 2007
- 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
- Male and females patients from 18 to <80 years of age
- Clinical diagnosis of type 2 diabetes mellitus
- Duration of diabetes of >3 years and <20 years
- Glycemic control at upper end of acceptable level or sub-optimal in control (HbA1c between 7.0% and 12?0%)
- Confirmation of diagnosis of diabetes such as a history of 2 hour postprandial blood glucose >11.1 mmol/L (200 mg/dL) or following a glucose tolerance test
- A minimum of 2 months of treatment with a stable dose of one or more of the following anti-hyperglycemic agents: sulphonylureas, alpha glucosidase inhibitors, metformin, meglitinides, thiazolidinediones and/or Lantus basal insulin therapy
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- FBG:>6 mmol/L (108 mg/dL)
- C-peptide: >0.5 nmol/L
- BMI <38 kg/m2
- Baseline DLco, FVC, FEV1 >75% of predicted normal
- Subjects who, in the opinion of the Investigator, will be able to complete this study
- Written informed consent
Who cannot join
- Severe complications of diabetes including history of: blindness from or grade III or IV diabetic retinopathy, renal failure requiring dialysis or transplantation, amputation of limbs or digits related to diabetic vasculopathy or foot ulcers
- Treatment with another investigational drug within 3 months prior to study entry and for the duration of the study
- History of drug or alcohol dependency
- Significant hepatic disease (as evidenced by ALT or AST >3 times the normal upper reference range or bilirubin >1.5 times the normal upper reference range)
- Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females) or proteinuria >1,000 mg/24 hours
- History of chronic obstructive pulmonary disease, or history of other known chronic pulmonary diseases, such as reactive airway disease, chronic bronchitis, emphysema, or asthma
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- 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
- Smokers
- Current use of preprandial or prandially administered fast-acting or rapid acting insulin or insulin analogs
- Previous participation in a TI or TP clinical trial
- Allergy to insulin or to any drugs to be used as part of the clinical trial
- History of malignancy within 5 years of study entry (other than basal cell carcinoma)
- Anemia (hemoglobin level less than 11 g/dL for females or 12 g/dL for males at study entry)
- Diagnosis of Acquired Immunodeficiency Syndrome (AIDS) and Aids Related Complex A major psychiatric disorder that will preclude satisfactory participation in this study
- Subjects who have had a myocardial infarction or stroke within the preceding 6 months
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
- History of severe or multiple allergies
- Progressive fatal disease
- Recent loss (within the past 2 months) of >5% of body weight
- Evidence of "moderate" or greater ketones in urine or history of ketoacidosis
- Use of medications known to modify glucose metabolism or the ability to recover from hypoglycemia such as oral, parenteral and inhaled steroids, or greater than 25 mg hydrochlorothiazide daily
- Women who are pregnant or lactating
- 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).
About this study
Official title: A Randomized, Double-blind, Controlled, Stepwise Titration Study to Evaluate Dose Response to Prandial Administration of Inhaled Technosphere/Insulin or Technosphere in Patients With Type 2 Diabetes Mellitus Who Are Sub-optimally Treated
Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled
- 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 | 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 6) to end of treatment (week 17)
Measured: measured from week 6 (baseline) to week 17
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration
Measured: at weeks 4, 6, 11 and 17
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration
Measured: at weeks 4, 6, 11 and 17
Secondary outcomes (2)
Fasting blood glucose concentration compared to week 6 (baseline)
Measured: at weeks 4, 6, 11 and 17
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Measured: 18 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 startJun 2004
- Primary completionAug 2005
- Study completionAug 2007
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511732
- Sponsor's protocol ID
- MKC-TI-005
- Status last verified
- Apr 2012
- First submitted
- 3 Aug 2007
- Last updated
- 30 Apr 2012
- Results posted
- No
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
- A Randomized, Double-blind, Controlled, Stepwise Titration Study to Evaluate Dose Response to Prandial Administration of Inhaled Technosphere/Insulin or Technosphere in Patients With Type 2 Diabetes Mellitus Who Are Sub-optimally Treated
- ClinicalTrials.gov ID
- NCT00511732
- Acronym / sponsor ID
- MKC-TI-005
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2007 (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.
Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled
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 | 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 (12 listed)
- Male and females patients from 18 to <80 years of age
- Clinical diagnosis of type 2 diabetes mellitus
- Duration of diabetes of >3 years and <20 years
- Glycemic control at upper end of acceptable level or sub-optimal in control (HbA1c between 7.0% and 12?0%)
- Confirmation of diagnosis of diabetes such as a history of 2 hour postprandial blood glucose >11.1 mmol/L (200 mg/dL) or following a glucose tolerance test
Key exclusion criteria (24 listed)
- Severe complications of diabetes including history of: blindness from or grade III or IV diabetic retinopathy, renal failure requiring dialysis or transplantation, amputation of limbs or digits related to diabetic vasculopathy or foot ulcers
- Treatment with another investigational drug within 3 months prior to study entry and for the duration of the study
- History of drug or alcohol dependency
- Significant hepatic disease (as evidenced by ALT or AST >3 times the normal upper reference range or bilirubin >1.5 times the normal upper reference range)
- Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females) or proteinuria >1,000 mg/24 hours
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 |
| Technosphere PlaceboTechnosphere Inhalation Powder | Drug | Technosphere Inhalation Powder |
Primary outcome
HbA1c change from baseline (week 6) to end of treatment (week 17)
Time frame: measured from week 6 (baseline) to week 17
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.
Time frame: at weeks 4, 6, 11 and 17
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)
Time frame: at weeks 4, 6, 11 and 17
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration
2 secondary outcomes
Fasting blood glucose concentration compared to week 6 (baseline)
Time frame: at weeks 4, 6, 11 and 17
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time frame: 18 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.
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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.
Anders Boss study director
Mannkind Corporation
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 12 inclusion and 24 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 6) to end of treatment (week 17) (time frame: measured from week 6 (baseline) to week 17). 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 30 Apr 2012.