Status:
WITHDRAWN
An Open-Label Extension to Protocol 09-1, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from study #09-1 wh...
Detailed Description
This is an open-label extension study for subjects who participated in the control arm of study #09-1 (A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastroint...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Control subjects from study # 09-1 who are not treatment failures and have completed 12 months of the study
- Age ≥21 years and ≤ 65 years
- Have signed an informed consent form within 30 days of week 52 visit in study #09-1.
- HbA1c ≥ 7.5% and ≤ 10%
- Stable (s) doses (up to 2) of anti -diabetes medication(s) for a minimum of 3 months prior to enrollment with at least one at minimum required dose as outlined below:
- MET (≥1500 mg/day) OR
- SU (based on doses specified below) Generic Name (brand name) minimum required dose
- Glimepiride (Amaryl) 4 (mg/day) Glipizide (Glucotrol) 20 (mg/day) Glipizide (Glucotrol XL) 10 (mg/day) Glyburide (Micronas, Diabeta) 10 (mg/day) Micronized Glyburide (Glynase) 6 (mg/day) Chlorpropamide (Diabinese) 350 (mg/day) Tolazamide (Tolinase 500 (mg/day) Tolbutamide (Orinase) 1500 (mg/day) OR
- DPP-4i (based on doses specified below) Generic Name (brand name) minimum required dose Sitagliptin (Januvia®) 50 (mg/day) Saxagliptin (Onglyza®) 2.5 (mg/day) Linagliptin (Tradjenta ®) 5 (mg/day) Alogliptin (Nesina®) 12.5 (mg/day)
- TZD (based on doses specified below) Generic Name (brand name) minimum required dose Rosiglitazone (Avandia®) 4 (mg/day) Pioglitazone (Actos®) 30 (mg/day)
- BMI ≥ 30 and ≤ 55
- Willing to comply with study requirements
- Documented negative pregnancy test in women of childbearing potential
- Women of childbearing potential not intending to become pregnant for the duration of their trial participation
- Exclusion Criteria
- Any change from the subject's previous health status from assessment for eligibility in pivotal trial phase (such as a new condition or major illness) that places the subject at undue risk by participating in the study
- C-peptide \< 1.0 ng/mL
- Triglyceride level \> 400 mg/dL
- Vitamin D deficiency (\<20ng/ml)
- Male subjects with serum Cr \>1.5 mg/dl or female subjects with Cr \>1.4 mg/dl
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
- Symptomatic kidney stones or gallstones within 6 months prior to baseline (within 30 days of week 52 visit from #09-1 study)
- Acute pancreatitis at the time of baseline (within 30 days of week 52 visit from #09-1 study)
- Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
- Currently taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g. aspirin, ibuprofen, etc.) within 10 days of the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
- Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
- Currently taking the following medications (at the time of enrollment) 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 Drugs known to affect GI motility (e.g. Reglan) Prescription or over-the-counter weight loss medication(s) Medications known to cause significant weight gain (refer to study reference manual (SRM) or weight loss (e.g. chemotherapeutics)
- Currently taking ≥ two of the following medications for type 2 diabetes; MET, SU, DDP-4i and TZD at baseline (within 30 days of week 52 visit from #09-1 study)
- Currently taking medications for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g. GLP1 or insulin) at baseline (within 30 days of week 52 visit from #09-1 study)
- Chronic use of narcotics, opiates, or benzodiazepines and other addictive tranquilizers
- Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- Active H. pylori (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
- Residing in a location without ready access to study site medical resources
- Documented weight loss of \> 10 pounds anytime during the 3 months prior to enrollment
Exclusion
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02293720
Start Date
April 1 2015
End Date
July 1 2016
Last Update
September 14 2016
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