The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547482
• Other study ID #: MC CR TAN2006-067
• Status: Terminated
• Phase: N/A
• First received: October 4, 2007
• Last updated: December 15, 2010
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2008
• Source: MetaCure (USA), Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The main purpose of this research study is to investigate whether the TANTALUS II System is effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes (high blood sugar) and are overweight. The research will also evaluate the impact on weight loss and will study other health conditions related to obesity.

This research study involves an experimental system. The experimental system is the TANTALUS System, which consists of the implantable portion that includes the implantable pulse generator (IPG) and three pairs of implantable leads. There are also three external parts (items that are used outside your body): the programmer, the charger, and the Patient Wand.

Description:

This is a randomized, double-blind and controlled, multi-center study. Three hundred (300) subjects with type 2 diabetes ranging from low BMI to BMI 45 (BMI ≥ 28 and ≤ 45) will be enrolled.

The duration of subject participation in the main portion of the study which includes the initial study and study extension periods is expected to be approximately 12 months. Upon completion of this period, subjects with a TANTALUS device shall continue to be followed clinically at six-month intervals (Safety Monitoring Period) until the FDA has made a determination regarding the safety and efficacy of the device.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Body mass index (BMI) = 28 and = 45 (kg/m2)

2. Type 2 diabetes >6 months

3. Type 2 diabetic subjects treated with oral anti-diabetic

4. Stable anti-diabetic medications =3 months prior to enrollment, six months for TZD

5. HbA1c =7.5% and = 9.5 % at Visit 1, subjects with T2DM duration > 10 yrs should have HbA1c =7.5% and = 9.0

6. Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications

7. Fasting blood glucose >120 and < 240 mg/dl at Visit 1, subjects with T2DM duration > 10 yrs should be >120 and =180.

8. Women with childbearing potential must agree to use adequate birth control methods

9. Stable weight - no significant change (variation < 5%) in the last 6 months

10. Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study

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

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

13. Alert, mentally competent,

14. Able to provide voluntary informed consent and HIPAA Authorization

Exclusion Criteria:

1. Receiving insulin therapy

2. Taking GLP-1, Amylin treatment (Byetta, Symlin)

3. Blood pressure levels of >180/100

4. Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done

5. Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics

6. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment

7. Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)

8. Prior wound healing problems due to Staphylococcus and Candida

9. Prior bariatric surgery

10. History of pancreatitis

11. History of peptic ulcer disease within 5 years of enrollment

12. Diagnosed with gastroparesis

13. Use of active medical devices (either implantable or external) such as ICD, pacemaker, 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.

14. Cardiac history that physician feels should exclude the patient

15. Use of another investigational device or agent in the 30 days prior to enrollment

16. A history of life-threatening disease within 5 years of enrollment

17. 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Device:
• TANTALUS(TM) System
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).

Locations

Country	Name	City	State
United States	Kaleida Health, Diabetes-Endocrinology Center of Western New York	Buffalo	New York
United States	University of Colorado at Denver Health Sciences Center	Denver	Colorado
United States	Scripps Clinic Del Mar	La Jolla / San Diego	California
United States	Cedars Sinai	Los Angeles	California
United States	Vanderbilt University School of Medicine	Nashville	Tennessee
United States	Comprehensive Weight Control Program Cornell Medical Center	New York	New York
United States	Mt. Sinai School of Medicine	NY	New York
United States	University of Pennsylvania	Pennsylvania	Pennsylvania
United States	Diabetes and Glandular Disease Clinic (DGD)	San Antonio	Texas
United States	Washington University School of Medicine in St. Louis	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MetaCure (USA), Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bohdjalian A, Prager G, Aviv R, Policker S, Schindler K, Kretschmer S, Riener R, Zacherl J, Ludvik B. One-year experience with Tantalus: a new surgical approach to treat morbid obesity. Obes Surg. 2006 May;16(5):627-34. — View Citation

Peles S, Petersen J, Aviv R, Policker S, Abu-Hatoum O, Ben-Haim SA, Gutterman DD, Sengupta JN. Enhancement of antral contractions and vagal afferent signaling with synchronized electrical stimulation. Am J Physiol Gastrointest Liver Physiol. 2003 Sep;285(3):G577-85. Epub 2003 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated.		At the end of the Initial Study Period	Yes
Secondary	Device/procedure-related adverse events;hypoglycemic events; Proportion of subjects with HbA1c less than 7.0;reduction of weight for both groups;improvement of glycemic control as measured by HbA1c		The end of the Initial Study Period	Yes

External Links

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