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

Sponsor
MetaCure (USA), Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01303315
Collaborator
(none)
20
Enrollment
13
Locations
3
Arms
5.9
Duration (Months)
1.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: TANTALUS System
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: GLP-1 receptor agonist therapy

Group 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.

Device: TANTALUS System
An Active Implantable Pulse Generator Medical Device for the treatment of Obesity and Diabetes Type 2 and Obesity
Other Names:
  • TANTALUS System, TANTALUS II

    		•
    Experimental: GLP-1 receptor agonist and TANTALUS

    Group 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

    Device: TANTALUS System
    An Active Implantable Pulse Generator Medical Device for the treatment of Obesity and Diabetes Type 2 and Obesity
    Other Names:
  • TANTALUS System, TANTALUS II

    		•
    Active Comparator: Subjects on TANTALUS therapy only

    Group 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

    Device: TANTALUS System
    An Active Implantable Pulse Generator Medical Device for the treatment of Obesity and Diabetes Type 2 and Obesity
    Other Names:
  • TANTALUS System, TANTALUS II

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [6 month]

      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%.

    Secondary Outcome Measures

    1. Glycemic and metabolic parameters [6 month]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male and female subjects 21 through 70 years of age

    2. Type 2 diabetes duration more than 6 months and less than 10 years

    3. 7.8% < HbA1c < 10.5% if T2DM duration less than or equal to 5 years

    4. 7.8% < HbA1c < 10.0% if T2DM duration more than 5 years

    5. BMI < 40 kg/m2

    6. Taking at least one oral anti-diabetic medication

    7. Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:

    1. 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

    1. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

    2. If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment

    3. If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment

    4. If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment

    5. Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial

    6. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System

    7. 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

    8. Able to provide voluntary informed consent

    Exclusion Criteria:

    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.

    2. Cardiac history that physician feels should exclude the subject from the study.

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fakultni Nemocnice U SV. Anny V Brne Brno Czech Republic 656 91
    2 Klinika gerontologická a metabolická, Hradec Kralove Czech Republic 500 05
    3 General University Hospital, Prague Czech Republic 128 08
    4 Prednosta OB Kliniky a.s., Prague Czech Republic 130 00
    5 Diabetes Zentrum Bad Mergentheim Germany
    6 Asklepios Klinik St. Georg Hamburg Germany 20099
    7 Diabetes-Praxis Muenster Münster Germany 48153
    8 'N. Paulescu' National Institute of Diabetes, Nutrition and Metabolic Diseases Bucharest Romania 79811
    9 CMI Dr Busegeanu Mihaela Magdalena-Ploiesti Bucharest Romania A
    10 Fundeni Hospital - Surgical Bucharest Romania A
    11 Sanatatea Ta Medical Center Bucharest Romania A
    12 Sf. Ioan Hospital - Surgical Bucharest Romania A
    13 Spitalul Pelican, Orada Bucharest Romania A

    Sponsors and Collaborators

    • MetaCure (USA), Inc.

    Investigators

    • Study Director: Walid Haddad, PhD, MetaCure Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MetaCure (USA), Inc.
    ClinicalTrials.gov Identifier:
    NCT01303315
    Other Study ID Numbers:
    • MC CPTAN2010-017
    • Position II
    First Posted:
    Feb 24, 2011
    Last Update Posted:
    Sep 22, 2016
    Last Verified:
    Jun 1, 2011
    Keywords provided by MetaCure (USA), Inc.
    C19 246 300
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Sep 22, 2016