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

This study has been terminated.
(Protocol design under review.)
Sponsor:
Information provided by:
MetaCure (USA), Inc.
ClinicalTrials.gov Identifier:
NCT00547482
First received: October 4, 2007
Last updated: December 15, 2010
Last verified: April 2008
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Overweight
Device: TANTALUS(TM) System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

Resource links provided by NLM:


Further study details as provided by MetaCure (USA), Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
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.
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).

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547482

Locations
United States, California
Scripps Clinic Del Mar
La Jolla / San Diego, California, United States, 92130
Cedars Sinai
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado at Denver Health Sciences Center
Denver, Colorado, United States, 80262
United States, Missouri
Washington University School of Medicine in St. Louis
St. Louis, Missouri, United States, 63110
United States, New York
Kaleida Health, Diabetes-Endocrinology Center of Western New York
Buffalo, New York, United States, 14209
Comprehensive Weight Control Program Cornell Medical Center
New York, New York, United States, 10021
Mt. Sinai School of Medicine
NY, New York, United States, 10029-6574
United States, Pennsylvania
University of Pennsylvania
Pennsylvania, Pennsylvania, United States, 19104-3309
United States, Tennessee
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
United States, Texas
Diabetes and Glandular Disease Clinic (DGD)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
MetaCure (USA), Inc.
Investigators
Study Chair: Harold Lebowitz, MD Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science
  More Information

Additional Information:
Publications:
Responsible Party: MetaCure (USA) Inc., MetaCure (USA), Iinc.
ClinicalTrials.gov Identifier: NCT00547482     History of Changes
Other Study ID Numbers: MC CR TAN2006-067
Study First Received: October 4, 2007
Last Updated: December 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MetaCure (USA), Inc.:
Type 2 Diabetes
Overweight
Obese

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014