What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include oral antidiabetic drugs like metformin, sulfonylureas, and DPP-4 inhibitors, as well as injectable therapies like GLP-1 receptor agonists and insulin. Metformin can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Sulfonylureas may lead to hypoglycemia and weight gain. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis and, rarely, pancreatitis. GLP-1 receptor agonists often result in gastrointestinal side effects like nausea and vomiting. Insulin therapy can cause hypoglycemia and weight gain. Endoscopic duodenal mucosal regeneration, a newer approach, aims to improve glycemic control with potentially fewer systemic side effects, but its long-term safety profile is still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that focus on different mechanisms of action. GLP-1 agonists like liraglutide and extended-release exenatide have been approved for their efficacy in improving glycemic control and cardiovascular outcomes. SGLT2 inhibitors, such as dapagliflozin, have also been approved and are noted for their benefits in reducing cardiovascular events. While the Endogenex Device for endoscopic duodenal mucosal regeneration is still under investigation, these FDA-approved treatments offer a range of options for managing Type 2 Diabetes effectively.

What other types of research exist?

Promising novel alternatives to the Endogenex Device for Type 2 Diabetes patients include: 1) Albiglutide, a weekly GLP-1 receptor agonist, which has shown efficacy in improving glycemic parameters in Japanese patients. 2) Imeglimin, which has demonstrated efficacy and safety in a 24-week trial as monotherapy. 3) Polyethylene glycol loxenatide (PEX168), which has shown positive results in a 24-week phase 3a trial. 4) Ipragliflozin, an SGLT2 inhibitor, which has been effective as an add-on therapy to insulin.

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Device

Novel Therapy for Type 2 Diabetes (REGENT-1-US Trial)

N/A

Waitlist Available

Research Sponsored by Endogenex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

22-65 years of age

Current diagnosis of T2D

Must not have

Not a candidate for upper GI endoscopy or general anesthesia

History of diabetic ketoacidosis or hyperosmolar nonketotic coma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new procedure using the Endogenex Device to help regenerate the lining of the small intestine. It targets patients with type 2 Diabetes who are not well-controlled on their current medications. The goal is to improve how their bodies process sugar and manage blood sugar levels better.

Who is the study for?

This trial is for adults aged 22-65 with type 2 diabetes, who have been unable to control their blood sugar levels despite taking 2-3 non-insulin medications. Participants should have a BMI of 24-40 and a stable weight, without any significant gastrointestinal or autoimmune diseases, no recent insulin use (except for gestational diabetes), and not be on certain other medications.

What is being tested?

The Endogenex Device is being tested in this study. It's an endoscopic tool designed to regenerate the duodenal mucosa in patients whose type 2 diabetes isn't well-controlled by current medications. The study will check how safe it is and if it can feasibly be used as a treatment option.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include those commonly associated with endoscopic procedures such as discomfort, bleeding or infection at the site of intervention. There could also be device-specific reactions that will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 65 years old.

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I have been diagnosed with type 2 diabetes.

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I am taking 2-3 diabetes medications that don't include insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an upper GI endoscopy or be put under general anesthesia.

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I have had diabetic ketoacidosis or a severe diabetic coma before.

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I have a weakened immune system.

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I have ongoing anemia or a blood disorder affecting hemoglobin.

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I have a history of an underactive thyroid.

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I have had surgery on my digestive system that changed its structure.

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I have used or am using insulin.

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I have had gastroparesis or other stomach/intestinal issues.

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I am currently taking medication that affects my stomach or bowel movements.

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I have had cancer within the last 5 years.

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I often don't notice when my blood sugar is too low.

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I have had pancreatitis or liver disease in the past.

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I have been diagnosed with type 1 diabetes.

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I have a history of heart rhythm problems or significant heart disease.

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My kidney function is reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4, 12, 24, 36, 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4, 12, 24, 36, 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 12, 24, 36, 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Safety Endpoint

Secondary study objectives

Changes in HbA1c

Changes in Weight

Changes in alanine aminotransferase (ALT)

+6 more

Other study objectives

Procedural Time

Procedural success

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionalExperimental Treatment1 Intervention

All eligible patients will receive the endoscopic Endogenex procedure.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes (T2DM) include GLP-1 receptor agonists, DPP-4 inhibitors, insulin therapy, and novel approaches like endoscopic duodenal mucosal regeneration. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, improving blood glucose control. DPP-4 inhibitors prevent the breakdown of incretin hormones, prolonging their action to increase insulin release and decrease glucagon levels. Insulin therapy directly supplements insulin to manage blood glucose levels. Endoscopic duodenal mucosal regeneration aims to improve insulin sensitivity and reduce insulin resistance by altering the mucosal lining of the duodenum. These treatments are crucial for T2DM patients as they target different aspects of glucose metabolism, offering comprehensive management of the disease and potentially improving long-term outcomes.

Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Combination therapy for the improvement of long-term macrovascular and microvascular outcomes in type 2 diabetes: Rationale and evidence for early initiation.DPP-4 inhibitors and GLP-1 analogues: for whom? Which place for incretins in the management of type 2 diabetic patients?