A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

NCT02709577 | Completed Phase 1 Results

• 1 other identifier: 06-5
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c Values From Baseline Measurement

  Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.

  Baseline to 24 weeks or 52 weeks

Secondary Outcomes (1)

• Absolute Weight Change

  24 weeks or 52 weeks

Study Arms (2)

EndoBarrier Gastrointestinal Liner

EXPERIMENTAL

Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.

Device: EndoBarrier Gastrointestinal Liner

Sham: endoscopy and standard of care

EXPERIMENTAL

Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.

Other: Sham: endoscopy and standard of care

Interventions

EndoBarrier Gastrointestinal Liner DEVICE

The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.

Also known as: GI Sleeve

EndoBarrier Gastrointestinal Liner

Sham: endoscopy and standard of care OTHER

Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes

Also known as: Control

Sham: endoscopy and standard of care

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 years and \< 55 years - Male or Female
• Patients with type 2 diabetes, treated for 10 years or less
• HbA1c level ≥ 7.0 and ≤ 10.0%
• Fasting glucose ≤ 240 mg/dl
• Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination
• BMI \> 30 and \<50
• Patients willing to comply with study requirements
• Patients who have signed an informed consent form
• Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study.

You may not qualify if:

• Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones
• Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis
• Patients requiring insulin
• Patients with lab evidence of probable insulin production failure (fasting C peptide serum level \< 1ng/ml)
• Patients with a weight loss of \> 10 lbs within the three months of screening
• Patients requiring prescription anticoagulation therapy
• Patients with iron deficiency and iron deficiency anemia
• Patients with a history of abnormal pathologies of the GI tract
• Patients with known gallstones or kidney stones prior to implant
• Known infection at the time of implant
• Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Pregnant or has the intention of becoming pregnant in the next 12 months
• Patients with a history of active kidney stones
• Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
• Previous GI surgery that could affect the ability to place the sleeve or the function of the implant

Sponsors & Collaborators

• Morphic Medical Inc.: lead
• Hospital Dipreca: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Manager of Clinical Affairs
• Organization: GI Dynamics, Inc.

kwoessner@gidynamics.com

781.357.3263

Study Officials

• Leonardo Rodriguez Grunert, MD

  Hospital Dipreca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 28, 2016
• Results First Posted: December 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share