Kurzfassung

The main objectives of this study are to evaluate the safety and efficacy of gastric stimulation (GCM) using the TANTALUS II System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated

Einschlusskriterien :
- Male and female aged 21 through 70 years
- Diagnosed with Type II Diabetes Mellitus (T”DM)
- Duration of T”DM for less than 10 years
- T2DM inadequately controlled with at least one but no...The main objectives of this study are to evaluate the safety and efficacy of gastric stimulation (GCM) using the TANTALUS II System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated

Einschlusskriterien :
- Male and female aged 21 through 70 years
- Diagnosed with Type II Diabetes Mellitus (T”DM)
- Duration of T”DM for less than 10 years
- T2DM inadequately controlled with at least one but no more than three oral agents
- HbA1c >= 7.5 and <= 9.5 % at baseline
- Stable HbA1c (change between historical value (less than 3 months before V1) and V1
value >= 0.5%)
- Fasting blood glucose >120 and <240 mg/dl at Baseline (V1)
- Body mass index (BMI) between 28 and 45 kg/m²
- Oral medication regimen stable for a minimum of 3 months prior to enrollment
- Stable weight, defined as no significant weight change (>5%) over the three months prior
to enrollment as reported by the subject`s medical record
- Under a physician`s care for the 3 months preceding enrollment
- Women with childbearing potential (i.e. not post-menopausal or surgically sterilized)
must agree to use adequate birth control mehtods and must agree not to conceive for
the duration of the study
- Alert, mentally competent, and able to understand and willing to comply with the
requirements of the clinical trial, and personally motivated to abide by the requirements
and restrictions of the clinical trial.
- Subjects who are complaint, willing and able to participate in the follow-up visits for the
duration of the study.
- Able to provide informed consent
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