Evaluation of the Tantalus System in Type 2 Diabetic Subjects

Study Overview
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Brief Summary
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Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.

Official Title
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Evaluation of the Tantalus System in Type 2 Diabetic Subjects

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: Implantable pulse generator and electrodes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T2DM subjects inadequately controlled on a maximum of three oral agents Subjects with HbA1c between 7 and 9% Subjects with FBG between 120 and 200 mg/dL Subjects who are 21-60 years old Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks Subjects with Body Mass Index (BMI) between 30-38 (inclusive) Subjects with waist circumference >94 cm (males) and >80 cm (females) Subjects on stable medication program for at least three months with any oral medication program Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial. Able to provide voluntary informed consent. Exclusion Criteria: Subjects at high risk of general anesthesia or surgery Subjects with prior pancreatitis Subjects with chronic hepatitis Subjects with elevated serum creatinine Subjects with proliferative diabetic retinopathy Subjects with gastroparesis or intestinal pseudo-obstruction Subjects with motility disorders of the GI tract Subjects who are receiving medications known to affect gastric motility Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures Subjects who are pregnant (proven by positive hCG), or lactating Subjects who have had prior bariatric surgery Subjects with a history of peptic ulcer disease Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period Subjects with a life-threatening co-morbidity or life expectancy of less than one year Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment Subjects with a history of malignant disease Subjects who are currently on chemotherapy treatment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable pulse generator and electrodes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the of device and/or procedure related adverse events |  |  | 
| Evaluation of blood chemistry, hematology and urinalysis |  |  | 
| Ability to record electrical activity from the stomach |  |  | 
| Ability to communicate between patient wand and the device. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decrease in the HbA1c values between baseline and end-of-treatment |  |  | 
| Reduction in the required medications due to improved glycemia. |  |  | 
| Significant reduction in weight loss between baseline and end-of-treatment |  |  | 
| Improvement in co-morbid parameters |  |  |