Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Study Overview
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Brief Summary
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Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.

Detailed Description
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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)

Official Title
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A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: Magnet Anastomosis System
* Drug: Best Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 30 to 50. Subject Type 2 Diabetes Criteria: T2DM diagnosis ≥6 months but < 10 years On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose) 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device Placement<br>The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created. | Device: Magnet Anastomosis System<br>* 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.<br>* Other names: MAS;Drug: Best Medical Management<br>* The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.<br>* Other names: No other intervention;|
| No Intervention: Control<br>The patients in this arm will receive the best medical management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c | The primary effectiveness endpoint is Mean change in HbA1c from baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Weight | 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 | 12 months | 
| Proportion of subjects achieving remission | Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association) | 12 months | 
| Mean change in diabetes medication | Change in diabetes medication requirements from baseline to 12 months | 12 months |