Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

• Magnet Anastomosis System (Device), also known as MAS: The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes.
• Best Medical Management (Drug), also known as No other intervention: The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.

Primary outcomes

• Mean change in HbA1c [12 months]: The primary effectiveness endpoint is Mean change in HbA1c from baseline

Secondary outcomes

• Mean change in Weight [12 months]: 12 month weight loss measured as a percent of total body weight loss and excess weight loss (using the BMI method) as well as weight/BMI change from baseline
• Proportion of subjects achieving remission [12 months]: Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)
• Mean change in diabetes medication [12 months]: Change in diabetes medication requirements from baseline to 12 months

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Body mass index (BMI) 30 to 50.
* Subject Type 2 Diabetes Criteria:

  1. T2DM diagnosis ≥6 months but < 10 years
  2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
  3. Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., <0.3% reduction)
  4. Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
* If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
* Able to understand and sign informed consent document
* Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions

Exclusion Criteria:

* Known or suspected allergy to nickel or titanium or Nitinol
* Type 1 Diabetes
* Use of injectable insulin
* Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
* Probable insulin production failure, defined as fasting serum C Peptide <1 ng/mL (0.3 nmol/l)
* Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
* Contraindication to general anesthesia
* Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
* Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
* Previous technically difficult or failed colonoscopy or endoscopy
* If on metformin, history of polycystic ovarian syndrome (PCOS)
* Unable or unwilling to perform home blood glucose monitoring
* History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
* Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
* Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
* Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)

• Rudolf H Buxhoeveden, Principal investigator, Bariatric Surgeon at Hospital Aleman