Back to resultsThe TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
Primary Purpose
Type 2 Diabetes Mellitus, Overweight
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TANTALUS(TM) System
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes, Overweight, Obese
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)
- Type 2 diabetes >6 months
- Type 2 diabetic subjects treated with oral anti-diabetic
- Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD
- HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration > 10 yrs should have HbA1c ≥7.5% and ≤ 9.0
- Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
- Fasting blood glucose >120 and < 240 mg/dl at Visit 1, subjects with T2DM duration > 10 yrs should be >120 and ≤180.
- Women with childbearing potential must agree to use adequate birth control methods
- Stable weight - no significant change (variation < 5%) in the last 6 months
- Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
- 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 II System
- Alert, mentally competent,
- Able to provide voluntary informed consent and HIPAA Authorization
Exclusion Criteria:
- Receiving insulin therapy
- Taking GLP-1, Amylin treatment (Byetta, Symlin)
- Blood pressure levels of >180/100
- Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done
- Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
- Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
- Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
- Prior wound healing problems due to Staphylococcus and Candida
- Prior bariatric surgery
- History of pancreatitis
- History of peptic ulcer disease within 5 years of enrollment
- Diagnosed with gastroparesis
- 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.
- Cardiac history that physician feels should exclude the patient
- Use of another investigational device or agent in the 30 days prior to enrollment
- A history of life-threatening disease within 5 years of enrollment
- Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Sites / Locations
- Scripps Clinic Del Mar
- Cedars Sinai
- University of Colorado at Denver Health Sciences Center
- Washington University School of Medicine in St. Louis
- Kaleida Health, Diabetes-Endocrinology Center of Western New York
- Comprehensive Weight Control Program Cornell Medical Center
- Mt. Sinai School of Medicine
- University of Pennsylvania
- Vanderbilt University School of Medicine
- Diabetes and Glandular Disease Clinic (DGD)
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control
Treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated.
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
Full Information
NCT ID
NCT00547482
First Posted
October 4, 2007
Last Updated
December 15, 2010
Sponsor
MetaCure (USA), Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00547482
Brief Title
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
Official Title
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Protocol design under review.
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MetaCure (USA), Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight
Keywords
Type 2 Diabetes, Overweight, Obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
TANTALUS(TM) System
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)
Type 2 diabetes >6 months
Type 2 diabetic subjects treated with oral anti-diabetic
Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD
HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration > 10 yrs should have HbA1c ≥7.5% and ≤ 9.0
Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications
Fasting blood glucose >120 and < 240 mg/dl at Visit 1, subjects with T2DM duration > 10 yrs should be >120 and ≤180.
Women with childbearing potential must agree to use adequate birth control methods
Stable weight - no significant change (variation < 5%) in the last 6 months
Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study
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 II System
Alert, mentally competent,
Able to provide voluntary informed consent and HIPAA Authorization
Exclusion Criteria:
Receiving insulin therapy
Taking GLP-1, Amylin treatment (Byetta, Symlin)
Blood pressure levels of >180/100
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
Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment
Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
Prior wound healing problems due to Staphylococcus and Candida
Prior bariatric surgery
History of pancreatitis
History of peptic ulcer disease within 5 years of enrollment
Diagnosed with gastroparesis
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.
Cardiac history that physician feels should exclude the patient
Use of another investigational device or agent in the 30 days prior to enrollment
A history of life-threatening disease within 5 years of enrollment
Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Lebowitz, MD
Organizational Affiliation
Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Clinic Del Mar
City
La Jolla / San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Cedars Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado at Denver Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Kaleida Health, Diabetes-Endocrinology Center of Western New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Comprehensive Weight Control Program Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
NY
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
University of Pennsylvania
City
Pennsylvania
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States
Facility Name
Vanderbilt University School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Diabetes and Glandular Disease Clinic (DGD)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12801883
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. doi: 10.1152/ajpgi.00109.2003. Epub 2003 Jun 11.
Results Reference
background
PubMed Identifier
16687033
Citation
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. doi: 10.1381/096089206776945101.
Results Reference
result
Links:
URL
http://www.metacure.com
Description
Related Info
Learn more about this trial
The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study
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