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

NCT01303315 | Terminated DMC

• 2 other identifiers: MC CPTAN2010-017Position II
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 13

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

Conditions

Diabetes Mellitus, Type 2

Keywords

C19 246 300

Outcome Measures

Primary Outcomes (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%.

  6 month

Secondary Outcomes (1)

• Glycemic and metabolic parameters

  6 month

Study Arms (3)

GLP-1 receptor agonist therapy

OTHER

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

GLP-1 receptor agonist and TANTALUS

EXPERIMENTAL

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

Subjects on TANTALUS therapy only

ACTIVE COMPARATOR

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

Interventions

TANTALUS System DEVICE

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

Also known as: TANTALUS System, TANTALUS II

GLP-1 receptor agonist and TANTALUS; GLP-1 receptor agonist therapy; Subjects on TANTALUS therapy only

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 21 through 70 years of age
• Type 2 diabetes duration more than 6 months and less than 10 years
• % \< HbA1c \< 10.5% if T2DM duration less than or equal to 5 years
• % \< HbA1c \< 10.0% if T2DM duration more than 5 years
• BMI \< 40 kg/m2
• Taking at least one oral anti-diabetic medication
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• MetaCure (USA), Inc.: lead

Study Sites (13)

Fakultni Nemocnice U SV. Anny V Brne

Brno, 656 91, Czechia

Location

Klinika gerontologická a metabolická,

Hradec Králové, 500 05, Czechia

Location

General University Hospital,

Prague, 128 08, Czechia

Location

Prednosta OB Kliniky a.s.,

Prague, 130 00, Czechia

Location

Asklepios Klinik St. Georg

Hamburg, Hamburg, 20099, Germany

Location

Diabetes Zentrum

Bad Mergentheim, Germany

Location

Diabetes-Praxis Muenster

Münster, 48153, Germany

Location

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

Bucharest, 79811, Romania

Location

CMI Dr Busegeanu Mihaela Magdalena-Ploiesti

Bucharest, A, Romania

Location

Fundeni Hospital - Surgical

Bucharest, A, Romania

Location

Sanatatea Ta Medical Center

Bucharest, A, Romania

Location

Sf. Ioan Hospital - Surgical

Bucharest, A, Romania

Location

Spitalul Pelican, Orada

Bucharest, A, Romania

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Walid Haddad, PhD

  MetaCure Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 22, 2016

Record last verified: 2011-06

Locations

DE (3); RO (6); CZ (4)