Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes

This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.

This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication.

Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.

Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.

Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.

Inclusion Criteria:

• Subjects who are ≥ 18 years and ≤ 75 years of age.
• HbA1c at 7.5%-12%
• On oral glucose lowering drugs in a stable medication regimen
• Fasting plasma glucose level at ≥125mg/dL
• BMI 25-40 Kg/m2

Exclusion Criteria:

• Diagnosed Type I diabetes
• Serum C peptide <1ng/ml