Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: EndoBarrier: Duodenal-Jejunal Bypass Liner
52 weeks
Control Intervention1: Nil: Not applicable
Sponsors
GI Dynamics Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =25 years and = 60 years 2. Have signed an informed consent form 3. Durations of type 2 diabetes for = 15 years 4. HbA1c = 8.0% and = 11% 5. BMI = 25 kg/m2 and 6. Willing and able to comply with study requirements 7. Documented negative pregnancy test in women of childbearing potential 8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on one reliable form of contraception to prevent unwanted pregnancies 9. At least one year of medical history available, including detailed medical therapy and dosing information 10. Failed to achieve adequate HbA1c reduction after dual therapy for at least 3-month stable dosage of oral anti-diabetes medication(s), including metformin, and one or more of the following: SGLT-2 inhibitor, GLP-1 RA or, meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s. 11. Patients will discontinue Sulfonylureas 7 days prior to implant procedure.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with the EndoBarrier System 2. Previous GI surgery that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner, or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner 3. Known history of liver disease (e.g., viral, autoimmune, fibrosis/cirrhosis etiology, but not including incidental fatty liver) 4. Prior history of any hepatic abscess, or of any abscess requiring hospitalization, intravenous antibiotics or drainage. 5. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement 6. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis 7. Fasting C-peptide 8. Triglyceride level > 600 mg/dL 9. Uncorrected Vitamin D deficiency ( 10. Male patients with serum creatinine (Cr) >1.5 mg/dl or female patients with Cr >1.4 mg/dl 11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy 12. Height 13. Current or past alcohol addiction, current or past drug addiction, or current drug usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers 14. History of pancreatitis 15. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma) 16. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) 17. Thyroid disease unless controlled with medication 18. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post-implant procedure 19. Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure: Restricted Medications/Supplements Systemic corticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g. Metoclopramide) Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics) Supplements that are known or suspected to increase bleeding risk including but not limited to: Gingko biloba Ginseng Vitamins C & E Turmeric St. John’s wort Evening primrose oil Feverfew Green Tea Extract 20. Allergy or hypersensitivity to cephalosporins or penicillin and all equivalent antibiotics 21. Active ulcer disease. 22. History of Crohn’s disease, atresias or untreated stenoses 28. Unintentional weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization 29. Positive Fecal Immunochemical Test (FIT) at time of screening 30. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in HbA1c value from baseline to 12 months.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of total cholesterol, LDL, HDL, triglycerides and ratio of TG/HDL cholesterol at 12 months (52 weeks), compared to baselineTimepoint: 12th month;Change in HOMA-IR (using fasting glucose and fasting insulin) by 12 months (52 weeks), compared to baseline.Timepoint: 12th month;Diabetes Treatment Satisfaction Questionnaire (DTSQ) and weight impact validated questionnaire Impact of Weight on Quality of Life (IWQOL-lite) at 12 months (52 weeks), compared to baseline.Timepoint: 12th month;Incidence of severe or nocturnal hypoglycemic events during implant period.Timepoint: 12th month;Lower risk of CKD as demonstrated by combination of improved levels of eGFR and albumin to creatinine ratio.Timepoint: 12th month;Nonalcoholic Fatty Liver Disease (NFLD) at 12 months compared to baseline as measured by LFTTimepoint: 12th month;Proportion of patients who achieve an HbA1c value of less than 7% by 12 months (52 weeks).Timepoint: 12th months;Proportion of patients who achieve percent total body weight loss more than or equal to 5% at 12 months (52 weeks).Timepoint: 12th month;Reduction in additional diabetes medication.Timepoint: 12th month;Reduction in Nonalcoholic Steatohepatitis (NASH) at 12 months compared to baseline as measured by FirbroscanTimepoint: 12th month;Reduction of fasting blood glucose values at 12 months (52 weeks days), compared to baseline.Timepoint: 12th month;Reduction of insulin dosage at 12 months (52 weeks)Timepoint: 12th month;Reduction of systolic blood pressure values at 12 months (52 weeks), compared to baselineTimepoint: 12th month | — |
Countries
India
Contacts
Public ContactDr Tania Talwar
Apollo Hospitals Hyderabad
Outcome results
None listed