Type 2 DiabetesPhase 1NCT00276471
Evaluation of the Tantalus System in Type 2 Diabetic Subjects
A Phase 1 study testing Implantable pulse generator and electrodes in people with Type 2 Diabetes and Obesity, run by MetaCure Limited at 1 site in Austria.
Trial summary
Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Implantable pulse generator and electrodes
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2005to Jun 2007
- Phase
- Phase 1
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- T2DM subjects inadequately controlled on a maximum of three oral agents
- Subjects with HbA1c between 7 and 9%
- Subjects with FBG between 120 and 200 mg/dL
- Subjects who are 21-60 years old
- Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
- Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
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- Subjects with waist circumference >94 cm (males) and >80 cm (females)
- Subjects on stable medication program for at least three months with any oral medication program
- Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
- Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
- Able to provide voluntary informed consent.
Who cannot join
- Subjects at high risk of general anesthesia or surgery
- Subjects with prior pancreatitis
- Subjects with chronic hepatitis
- Subjects with elevated serum creatinine
- Subjects with proliferative diabetic retinopathy
- Subjects with gastroparesis or intestinal pseudo-obstruction
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- Subjects with motility disorders of the GI tract
- Subjects who are receiving medications known to affect gastric motility
- Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
- Subjects who are pregnant (proven by positive hCG), or lactating
- Subjects who have had prior bariatric surgery
- Subjects with a history of peptic ulcer disease
- Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
- Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
- Subjects with a life-threatening co-morbidity or life expectancy of less than one year
- Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
- Subjects with a history of malignant disease
- Subjects who are currently on chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Implantable pulse generator and electrodes
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable pulse generator and electrodesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the of device and/or procedure related adverse events
Evaluation of blood chemistry, hematology and urinalysis
Ability to record electrical activity from the stomach
Ability to communicate between patient wand and the device.
Secondary outcomes (4)
Significant decrease in the HbA1c values between baseline and end-of-treatment
Reduction in the required medications due to improved glycemia.
Significant reduction in weight loss between baseline and end-of-treatment
Improvement in co-morbid parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetaCure Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernhard Ludvik, Prof., Principal investigator, Allgemeinen Krankenhauses der Stadt Wein AkH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276471
- Sponsor's protocol ID
- MC PT TAN2005-013
- Status last verified
- Jan 2012
- First submitted
- 12 Jan 2006
- Last updated
- 2 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tantalus System in Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00276471
- Acronym / sponsor ID
- MC PT TAN2005-013
- Conditions
- Type 2 Diabetes, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- MetaCure LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Jan 2006 (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.
Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- T2DM subjects inadequately controlled on a maximum of three oral agents
- Subjects with HbA1c between 7 and 9%
- Subjects with FBG between 120 and 200 mg/dL
- Subjects who are 21-60 years old
- Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
Key exclusion criteria (18 listed)
- Subjects at high risk of general anesthesia or surgery
- Subjects with prior pancreatitis
- Subjects with chronic hepatitis
- Subjects with elevated serum creatinine
- Subjects with proliferative diabetic retinopathy
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 |
|---|---|---|
| Implantable pulse generator and electrodes | Device | – |
Primary outcome
Evaluation of the of device and/or procedure related adverse events
Evaluation of blood chemistry, hematology and urinalysis
Ability to record electrical activity from the stomach
Ability to communicate between patient wand and the device.
4 secondary outcomes
Significant decrease in the HbA1c values between baseline and end-of-treatment
Reduction in the required medications due to improved glycemia.
Significant reduction in weight loss between baseline and end-of-treatment
Improvement in co-morbid parameters
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 2 Feb 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.
Bernhard Ludvik, Prof. principal investigator
Allgemeinen Krankenhauses der Stadt Wein AkH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implantable pulse generator and electrodes in people with Type 2 Diabetes and Obesity, run by MetaCure Limited at 1 site in Austria.
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 11 inclusion and 18 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 2 Feb 2012. 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 Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluation of the of device and/or procedure related adverse events. The study lists 4 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 2 Feb 2012.