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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01303315
• Other study ID #: MC CPTAN2010-017
• Secondary ID: Position II
• Status: Terminated
• Phase: N/A
• First received: February 23, 2011
• Last updated: September 21, 2016
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: June 2011
• Source: MetaCure (USA), Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionRomania: Ethics CommitteeSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics CommitteeCzech Republic: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Czech Republic	Fakultni Nemocnice U SV. Anny V Brne	Brno
Czech Republic	Klinika gerontologická a metabolická,	Hradec Kralove
Czech Republic	General University Hospital,	Prague
Czech Republic	Prednosta OB Kliniky a.s.,	Prague
Germany	Diabetes Zentrum	Bad Mergentheim
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Diabetes-Praxis Muenster	Münster
Romania	'N. Paulescu' National Institute of Diabetes, Nutrition and Metabolic Diseases	Bucharest
Romania	CMI Dr Busegeanu Mihaela Magdalena-Ploiesti	Bucharest
Romania	Fundeni Hospital - Surgical	Bucharest
Romania	Sanatatea Ta Medical Center	Bucharest
Romania	Sf. Ioan Hospital - Surgical	Bucharest
Romania	Spitalul Pelican, Orada	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
MetaCure (USA), Inc.

Countries where clinical trial is conducted

Czech Republic,  Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	6 month	Yes
Secondary	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	6 month	Yes