Clinical trial NCT01303315: TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy
Official title: TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: C19 246 300
Lead sponsor: MetaCure (USA), Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
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
timeFrame: 6 month
Secondary outcomes:
measure: Glycemic and metabolic parameters
timeFrame: 6 month
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Fakultni Nemocnice U SV. Anny V Brne
city: Hradec Kralove
country: Czech Republic
facility: Klinika gerontologická a metabolická,
city: Prague
country: Czech Republic
facility: General University Hospital,
city: Prague
country: Czech Republic
facility: Prednosta OB Kliniky a.s.,
city: Bad Mergentheim
country: Germany
facility: Diabetes Zentrum
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Münster
country: Germany
facility: Diabetes-Praxis Muenster
city: Bucharest
country: Romania
facility: 'N. Paulescu' National Institute of Diabetes, Nutrition and Metabolic Diseases
city: Bucharest
country: Romania
facility: CMI Dr Busegeanu Mihaela Magdalena-Ploiesti
city: Bucharest
country: Romania
facility: Fundeni Hospital - Surgical
city: Bucharest
country: Romania
facility: Sanatatea Ta Medical Center
city: Bucharest
country: Romania
facility: Sf. Ioan Hospital - Surgical
city: Bucharest
country: Romania
facility: Spitalul Pelican, Orada
Study officials:
affiliation: MetaCure Limited
name: Walid Haddad, PhD
role: STUDY_DIRECTOR
References: