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Diabetes Mellitus, Type 2CrossoverNCT01303302

The TANTALUS® II for the Treatment of Type 2 Diabetes

A study testing Tantalus System in people with Diabetes Mellitus, Type 2, run by MetaCure (USA), Inc. at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation using the TANTALUS System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Tantalus System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
7 sitesin 4 countries
Study dates
Apr 2008to Aug 2015
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects 18 through 70 years of age
  • Body mass index >=28 and <=45 (kg/m2)
  • Type 2 diabetes duration more than 6 month
  • Type 2 diabetic sublecys treated with oral anti-diabetic agents
  • Stable anti-diabetic medication for at least 3 month prior to enrollment
  • HbA1c >=7.5% and <=9.5% on visit 1; subjects with T2DM duration .10 years should have <=9.0% at visit 1
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  • Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
  • Fasting blood glucose >120 and < 240 mg/dl on visit 1; subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
  • Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
  • Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
  • If taking these medication, stable anti-hepertensive and lipid-lpwering medication for at least one month prior to enrollment
  • If subject is under unti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
  • Wllingness to refrain from using prescription, over the counter or herbal weight loss product for the duration of the trial
  • Ability and willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II Syatem
  • Alert, mentally competant, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
  • Able to provide voluntary informed consent

Who cannot join

  • Insulin therapy
  • Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affec gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
  • Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
  • Experiencing sever and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
  • Prior wound healing problems
  • Diagnosed with past or present psychiatric condition that may impair his or her ability to comply with the study procedure
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  • Use of anti-pchichotic medication
  • Diagnosed with an eating disorder such as bulimia or binge eating
  • Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)
  • Hiatal hernia requiring surgical repair or paraesophageal hernia
  • Pregnant or lactating Diagnosed with impared liver function (liver enzyms 3 times graeted than normal)
  • Any prior bariatric surgery
  • Ant history of pancreattitis Any history of peptic ulcer disease within 5 years of enrollemnt Diagnosed with gastroparesis or GI mobility disorder Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn) Subject using an external active device who are able anf willing to avoid use of the device during the study may be enrolled.
  • Cardiac history that physician feels should exclude the subject from the study.
  • Use of anotherc investigational device agent in the 30 dayes prior to enrollemnt
  • A history of life threatening diseas within 5 years of enrollment
  • Change in diabetic medication from between visit 1 and visit 3
  • Any additional condition(S) that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Germany4 sites

  • Gemeinschaftspraxis Drs. Klausmann

    Aschaffenburg, D-63739.

  • Arzt für Innere Medizin und Endokrinologie

    Bad Nauheim

  • Krankenhaus Sachsenhausen

    Frankfurt, 60594

  • Diabetes-Praxis Muenster

    Münster, 48153

Other trials in Germany

Austria1 site

  • Medical University of Vienna

    Vienna

Other trials in Austria

Italy1 site

  • Università Cattolica S. Cuore

    Rome, 00168

Other trials in Italy

Poland1 site

  • CMKP- Centrum Medyczne Kształcenia Podyplomowego

    Warsaw, 01-813

Other trials in Poland

About this study

Official title: The TANTALUS® II for the Treatment of Type 2 Diabetes: A Single-Blind Cross-Over Study

Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation using the TANTALUS System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated

Read the detailed description

This is a multi-center, single blind, randomized, cross-over study. Subject enrollment will continue until forty (40) eligible participants have been randomized into one of the two groups. Subjects will undergo baseline valuation (Visit 1) during which the stability of their glycemic parameters, medical treatment and medical condition will be assessed. Subjects meeting all inclusion/exclusion criteria at Visit 2 will be implanted. Approximately three days prior to their implantation, subjects will be seen for their 'pre-implant' medical evaluation (Visit 3). One week after implant (Visit 5, Week 1)subjects will be randomized into one of two groups (A and B).

"Group A" subjects will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for the first 24 week period (Period 1). At Visit 10, (week 25 and end of Period 1), Group A subjects will have their devices turned "OFF" for the next 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group A subjects will have their devices turned "On" for the next 24 weeks period (Period 3) "Group B" subjects will not have their device activated for the first 24 weeks (Period 1) of their study. At Visit 10 (week 25 end of Period 1), Group B subjects devices will have their device turned "ON" (i.e. activated to deliver CGM signals) for the 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group B subjects will have their devices turned "OFF" for the next 24 weeks period (Period 3).

Being tested
Tantalus System
Keywords
C19 246 300
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.

  • Tantalus SystemDevice

    Also called TANTALUS II

    The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes

  • TANTALUS systemDevice

    Also called TANTALUS II

    The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes. In the sham comparator the device is off.

Study groups in NCT01303302
Study groupRoleWhat they receive
GCM stimulationActive comparatorThe patient will be implanted with a gastric contractility modulation (GCM) stimulation system using the TANTALUS System for treatment of type 2 diabetic patients.
Receives: Device: Tantalus System
Device offSham comparatorThe TANTALUS System is implanted but is off
Receives: Device: TANTALUS system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the differences in HbA1c levels

    Comparison of the differences in HbA1c levels between treatment and control groups between changes occurred during period 2 to period 3

    Measured: One year

Secondary outcomes (1)

  1. Improvement in weigth and metabolic parameters

    • Trends in weight loss will be of a reduction in weight during periods 2 and 3.
    • Trends in improvement in metabolic parameters such as waist circumference, blood pressure and lipids occurred during period 2 to period 3.
    • Difference in device related Adverse Events between treatment and control groups between periods of active and inactive therapy.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303302
Sponsor's protocol ID
MC CP TAN2007-032
Other IDs
Cross-over
Acronym
Crossover
Status last verified
Sep 2016
First submitted
23 Feb 2011
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Tantalus System in people with Diabetes Mellitus, Type 2, run by MetaCure (USA), Inc. at 7 sites in 4 countries.

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 16 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Austria, Italy, Poland. 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. 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.

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?

Comparison of the differences in HbA1c levels (time frame: One year). 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 NCT01303302.

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 22 Sep 2016.

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