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Diabetes Mellitus, Type 2NCT01303315

TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy

A study testing TANTALUS System in people with Diabetes Mellitus, Type 2, run by MetaCure (USA), Inc. at 13 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy Read more about this study

Who is it for?
Ages 21 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?
No, everyone receives an active treatment
How many people
20 participants
Where
13 sitesin 3 countries
Study dates
Jan 2011to Jul 2011
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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects 21 through 70 years of age
  • Type 2 diabetes duration more than 6 months and less than 10 years
  • 7.8% < HbA1c < 10.5% if T2DM duration less than or equal to 5 years
  • 7.8% < HbA1c < 10.0% if T2DM duration more than 5 years
  • BMI < 40 kg/m2
  • Taking at least one oral anti-diabetic medication
Show all 16Show fewer
  • Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:
  • The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration less than 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration greater than 5 years b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks
  • Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
  • If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
  • If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
  • Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
  • Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
  • Alert, mentally competent, 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

  • 1. Insulin therapy within the last 3 months 2. GLP-1 receptor agonist therapy longer than 3 months 3. Diagnosed with renal dysfunction or history of renal dysfunction 4. Taking medications known to affect gastric motility 5. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months 6. Experiencing severe and progressing diabetic complications (7. Prior wound healing problems 8. Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures 9. Use of anti-psychotic medications 10. Diagnosed with eating disorder such as bulimia or binge eating 11. Obesity due to an endocrinopathy 12. Hiatal hernia requiring surgical repair or a paraesophageal hernia 13. Pregnant or lactating 14. Diagnosed with impaired liver function 15. Any prior bariatric surgery 16. Any history of pancreatitis 17. Any history of peptic ulcer disease within 5 years of enrollment 18. Diagnosed with Gastroparesis or other GI motility disorder 19. Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
  • 20. Cardiac history that physician feels should exclude the subject from the study.
  • 21. Use of another investigational device or agent in the 30 days prior to enrollment 22. A history of life-threatening disease within 5 years of enrollment 23. 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

13 sites in 3 countries.

13 sites in 3 countries

Romania6 sites

  • 'N. Paulescu' National Institute of Diabetes, Nutrition and Metabolic Diseases

    Bucharest, 79811

  • CMI Dr Busegeanu Mihaela Magdalena-Ploiesti

    Bucharest, A

  • Fundeni Hospital - Surgical

    Bucharest, A

  • Sanatatea Ta Medical Center

    Bucharest, A

  • Sf. Ioan Hospital - Surgical

    Bucharest, A

  • Spitalul Pelican, Orada

    Bucharest, A

Other trials in Romania

Czechia4 sites

  • Fakultni Nemocnice U SV. Anny V Brne

    Brno, 656 91

  • Klinika gerontologická a metabolická,

    Hradec Králové, 500 05

  • General University Hospital,

    Prague, 128 08

  • Prednosta OB Kliniky a.s.,

    Prague, 130 00

Other trials in Czechia

Germany3 sites

  • Diabetes Zentrum

    Bad Mergentheim

  • Asklepios Klinik St. Georg

    Hamburg, Free and Hanseatic City of Hamburg, 20099

  • Diabetes-Praxis Muenster

    Münster, 48153

Other trials in Germany

About this study

To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy

Read the detailed description

The present protocol will address whether the effects of the TANTALUS treatment are complimentary to GLP-1 treatment which is only partially effective or whether it can replace GLP-1 treatment in individuals who cannot tolerate GLP-1 agonists because of unacceptable side effects.

This investigation will be a 3 arm multicenter study which will enroll in a Run-In Period up to 400 with type 2 diabetes mellitus. This Run-In Period will facilitate screening the patients with the aim to have a maximum of 30 patients in each arm complete the Evaluation Period of 6 months. The study aims at evaluating the TANTALUS therapy compared to GLP-1 receptor agonist therapy by evaluating improvement in glycemic control and weight after 6 months of treatment in each of the 3 study groups, which are:

  • Group A: subjects on GLP-1 receptor agonist therapy only
  • Group B: subjects on GLP-1 receptor agonist therapy and TANTALUS therapy
  • Group C: subjects on TANTALUS therapy only
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 System, TANTALUS II

    An Active Implantable Pulse Generator Medical Device for the treatment of Obesity and Diabetes Type 2 and Obesity

Study groups in NCT01303315
Study groupRoleWhat they receive
GLP-1 receptor agonist therapyOtherGroup A: Subjects on GLP-1 receptor agonist therapy only. After run in of 12 weeks on GLP-1 receptor agonist therapy, Patients with HbA1c < 7.5 are moved to Group A, continue GLP-1 receptor agonist therapy, and then start the Evaluation Period These patients will not be implanted with the TANTALUS system.
Receives: Device: TANTALUS System
GLP-1 receptor agonist and TANTALUSExperimentalGroup B: subjects on GLP-1 receptor agonist therapy and TANTALUS therapy After run in of 12 weeks on GLP-1 receptor agonist therapy, Patients with HbA1c > 7.5 are moved to Group B, continue GLP-1 receptor agonist therapy, implanted with TANTALUS within 4 weeks, and then start the Evaluation Period
Receives: Device: TANTALUS System
Subjects on TANTALUS therapy onlyActive comparatorGroup C: subjects on TANTALUS therapy only After run in of 12 weeks on GLP-1 receptor agonist therapy, patients intolerant to low dosage of GLP-1 receptor agonist therapy will be implanted with the TANTALUS system
Receives: Device: TANTALUS System

What is being measured

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

  1. Decrees in HbA1c of at least 0.5 points and Weight loss of at least 3% of total body weight after 6 month of treatment

    Change in HbA1c and weight will be assessed at baseline and 24 weeks of treatment for Group A and C.

    Additionally, each group will be analyzed for the weight of decrease extent, the percentage of patients achieving the endpoint, and the percentage of patients that reach an HbA1c less than 7.0%.

    Measured: 6 month

Secondary outcomes (1)

  1. Glycemic and metabolic parameters

    • Glycemic Parameters (FBG, PPG)
    • Glycemic Dynamics (Glucose, Insulin, C-Peptide, and Glucagon Profiles) via MTT
    • Metabolic Parameters (WC, BP, Lipids, Gastric Emptying)
    • Gastric Hormones (GLP-1, GIP, Ghrelin, PYY, Pancreatic Polypeptide) via MTT

    Measured: 6 month

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 startJan 2011
  3. Primary completionJul 2011
  4. Study completionJul 2011

Why it stopped: Company strategic decision

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303315
Sponsor's protocol ID
MC CPTAN2010-017
Other IDs
Position II
Status last verified
Jun 2011
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 13 sites in 3 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 3 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: stopped early, 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 13 sites in Romania, Czechia, Germany. 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.

Are results available for this study?

The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.

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?

Decrees in HbA1c of at least 0.5 points and Weight loss of at least 3% of total body weight after 6 month of treatment (time frame: 6 month). 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 NCT01303315.

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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