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

This study has been terminated.
(Protocol design under review.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547482
First Posted: October 22, 2007
Last Update Posted: December 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MetaCure (USA), Inc.
October 4, 2007
October 22, 2007
December 16, 2010
September 2007
November 2009   (Final data collection date for primary outcome measure)
Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated. [ Time Frame: At the end of the Initial Study Period ]
Same as current
Complete list of historical versions of study NCT00547482 on ClinicalTrials.gov Archive Site
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 [ Time Frame: The end of the Initial Study Period ]
Same as current
Not Provided
Not Provided
 
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Overweight
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).
  • Sham Comparator: Control
    They will all be implanted but not activated for the Initial Study Period (24 weeks), followed by all subjects assigned to treatment (Control Group with device activation) in the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
    Intervention: Device: TANTALUS(TM) System
  • Active Comparator: Treatment
    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). They will be followed for the Initial Study Period (24 weeks), followed by the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
    Intervention: Device: TANTALUS(TM) System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00547482
MC CR TAN2006-067
Yes
Not Provided
Not Provided
MetaCure (USA) Inc., MetaCure (USA), Iinc.
MetaCure (USA), Inc.
Not Provided
Study Chair: Harold Lebowitz, MD Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science
MetaCure (USA), Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP