Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes

Endogenex, Inc.3 sites in 1 country20 target enrollmentOctober 29, 2021

ConditionsDiabetes Diabetes Type 2 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Endogenex, Inc.
Enrollment: 20
Locations: 3
Primary Endpoint: Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.

Detailed Description

Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the Endogenex procedure and followed up for 48 weeks.

Registry

clinicaltrials.gov

Start Date

October 29, 2021

End Date

May 29, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endogenex, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•22- 65 years of age
•Current diagnosis of T2D
•History of T2D for at least 3 years and less than or equal to 10 years
•HbA1C of 7.5-10.0%, inclusive
•BMI 24-40 kg/m2, inclusive
•On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit
•History of failed attempt to reach glycemic goal by lifestyle modifications
•Weight stability (defined as a \< 5% change in body weight) for at least 12 weeks prior to the screening visit
•Agree not to donate blood during participation in the study.
•Able to comply with study requirements and understand and sign the Informed Consent Form

Exclusion Criteria

•Diagnosed with type 1 diabetes
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma
•Probable insulin production failure, defined as overnight fasting C-peptide serum \<1 ng/mL (333pmol/l).
•Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in last 2 years.
•Current use of insulin
•Hypoglycemia unawareness
•History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit
•Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism may be included).
•Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
•Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.

Outcomes

Primary Outcomes

Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)

Time Frame: 12 weeks post-procedure

Number of participants experiencing device- or procedure-related serious adverse events (SAE)

Secondary Outcomes

Mean HbA1c by Follow-up Visit(at 4,12, 24, and 48 Weeks Post Procedure)
Mean Fasting Plasma Glucose (FPG) by Visit(Follow-up at 4,12, 24, 36, and 48 weeks post procedure)
Mean Weight by Follow-up Visit(Follow-up at 4,12, 24, 36, and 48 weeks post procedure)