A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics

NCT00973960 | Completed

• 1 other identifier: 09-2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes. The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.

  24 weeks

Secondary Outcomes (1)

• The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related).

  24 weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Type 2 Diabetes

You may qualify if:

• Age \> 18 years and \< 55 years - Male or Female
• BMI \> 30 BMI \<60
• Subjects with an HbA1c \> 7.5 and ≤ 10.0%
• Subjects with Type 2 diabetes who have been treated for ≤10 years
• Subjects on Metformin and/or Sulfonylurea
• History of failure with nonsurgical weight loss methods
• Subjects willing to comply with trial requirements
• Subjects who have signed an informed consent form
• Women who are post-menopausal, surgically sterile or on oral contraceptives and who do not plan on becoming pregnant during the course of the trial.

You may not qualify if:

• Treatment represents an unreasonable risk to the subject
• Subjects on oral diabetic medications other than Metformin or Sulfonylurea
• Subjects on insulin
• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects with a past medical history of hypoglycemia
• Subjects with abnormal gastric emptying at baseline, defined as \< 90% stomach emptied at 4 hours
• Subjects with a weight loss of \> 4.5 Kg (10 lbs) within the 12 Weeks of screening
• Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
• Pregnant or have intention of becoming pregnant for the duration of the trial
• Unresolved alcohol or drug addiction
• Subjects receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
• Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Flow Restrictor or the function of the implant.
• Subjects with active and uncontrolled GERD
• Subjects with symptomatic kidney stones prior to implant
• Subjects with iron deficiency and/or iron deficiency anemia

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (1)

Hospital Universidad Catolica

Santiago, Chile

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Escalona, MD

  Hospital Universidad Catolica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 8, 2011

Record last verified: 2011-08

Locations

CL (1)