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

This study has been terminated.
(Company strategic decision)
Sponsor:
Information provided by:
MetaCure (USA), Inc.
ClinicalTrials.gov Identifier:
NCT01303315
First received: February 23, 2011
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Device: TANTALUS System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy

Resource links provided by NLM:


Further study details as provided by MetaCure (USA), Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • Glycemic and metabolic parameters [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    • 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


Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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 Name: TANTALUS Syatem, TANTALUS II
Active Comparator: 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 Name: TANTALUS Syatem, 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 Name: TANTALUS Syatem, TANTALUS II

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
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    a. 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

  8. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  9. If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
  10. If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
  11. If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
  12. Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
  13. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
  14. 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
  15. 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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303315

Locations
Czech Republic
Fakultni Nemocnice U SV. Anny V Brne
Brno, Czech Republic, 656 91
Klinika gerontologická a metabolická,
Hradec Kralove, Czech Republic, 500 05
General University Hospital,
Prague, Czech Republic, 128 08
Prednosta OB Kliniky a.s.,
Prague, Czech Republic, 130 00
Germany
Diabetes Zentrum
Bad Mergentheim, Germany
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Diabetes-Praxis Muenster
Münster, Germany, 48153
Romania
'N. Paulescu' National Institute of Diabetes, Nutrition and Metabolic Diseases
Bucharest, Romania, 79811
CMI Dr Busegeanu Mihaela Magdalena-Ploiesti
Bucharest, Romania, A
Spitalul Pelican, Orada
Bucharest, Romania, A
Sanatatea Ta Medical Center
Bucharest, Romania, A
Sf. Ioan Hospital - Surgical
Bucharest, Romania, A
Fundeni Hospital - Surgical
Bucharest, Romania, A
Sponsors and Collaborators
MetaCure (USA), Inc.
Investigators
Study Director: Walid Haddad, PhD Metacure
  More Information

No publications provided

Responsible Party: Director of Clinical Trails, MetaCure (USA)
ClinicalTrials.gov Identifier: NCT01303315     History of Changes
Other Study ID Numbers: MC CPTAN2010-017, Position II
Study First Received: February 23, 2011
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Romania: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Czech Republic: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by MetaCure (USA), Inc.:
C19 246 300

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014