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Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes (REGENT-1-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014204
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
DyaMX Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Type 2 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Diabetes Mellitus Device: The Endogenex Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes
Actual Study Start Date : October 29, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Safety

Arm Intervention/treatment
Experimental: Interventional
All eligible patients will receive the endoscopic Endogenex procedure.
Device: The Endogenex Device
The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.




Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 12 weeks post-procedure ]
    Portion of participants experiencing device- or procedure-related serious adverse events (SAE)


Secondary Outcome Measures :
  1. Changes in HbA1c [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in HbA1c

  2. Changes in fasting plasma glucose [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in FPG

  3. Changes in insulin resistance [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in HOMA-IR

  4. Changes in post-prandial glucose [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes in PPG by mixed meal tolerance test

  5. Changes in Weight [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in weight

  6. Changes systolic and diastolic blood pressure [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in systolic and diastolic blood pressure

  7. Changes in alanine aminotransferase (ALT) [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in ALT

  8. Changes in aspartate aminotransferase (AST) [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Mean changes from baseline in AST

  9. Changes in glucose-lowering medication usage [ Time Frame: 4, 12, 24, 36, 48 weeks ]
    Changes in usage of glucose-lowering medications


Other Outcome Measures:
  1. Procedural success [ Time Frame: At the time of procedure ]
    Percentage of participants with successful DMR procedure

  2. Procedural Time [ Time Frame: At the time of procedure ]
    Time between catheter insertion to catheter removal



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 22- 65 years of age
  2. Current diagnosis of T2D
  3. History of T2D for at least 3 years and less than or equal to 10 years
  4. HbA1C of 7.5-10.0%, inclusive
  5. BMI 24-40 kg/m2, inclusive
  6. 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
  7. History of failed attempt to reach glycemic goal by lifestyle modifications
  8. Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the screening visit
  9. Agree not to donate blood during participation in the study.
  10. Able to comply with study requirements and understand and sign the Informed Consent Form
  11. Women of childbearing potential must be using an acceptable method of contraception throughout the study
  12. Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
  13. Proof of COVID 19 vaccination.

Exclusion Criteria:

  1. Diagnosed with type 1 diabetes
  2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  3. Probable insulin production failure, defined as overnight fasting C-peptide serum <1 ng/mL (333pmol/l).
  4. Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes) in last 2 years.
  5. Current use of insulin
  6. Hypoglycemia unawareness
  7. History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit
  8. 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).
  9. 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.
  10. 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.
  11. Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
  12. History of, or gastrointestinal symptoms suggestive of gastroparesis.
  13. Acute gastrointestinal illness in the previous 7 days
  14. Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
  15. History of chronic or acute pancreatitis.
  16. Known active hepatitis or active liver disease other than NASH/NAFLD.
  17. Alcoholic liver disease, as indicated by ANI > 0
  18. Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
  19. Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
  20. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
  21. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
  22. Use of drugs known to affect GI motility (e.g. Metoclopramide)
  23. Use of weight loss medications such as Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication)
  24. Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at >500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.
  25. Persistent anemia, defined as hemoglobin <10 g/dL.
  26. Known history of hemoglobinopathy.
  27. Known history of blood donation or transfusion within 3 months prior to the Screening Visit.
  28. Known history of cardiac arrythmia
  29. Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.
  30. Estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73m2 (estimated by MDRD).
  31. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
  32. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening)
  33. With any implanted electronic devices or duodenal metallic implants
  34. Not a candidate for upper GI endoscopy or general anesthesia.
  35. Active illicit substance abuse or alcoholism (>2 drinks/day regularly)
  36. Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
  37. Women breastfeeding
  38. Participating in another ongoing clinical trial of an investigational drug or device.
  39. Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
  40. Critically ill or has a life expectancy <3 years

    Additional exclusion criteria to be confirmed during the screening process:

  41. HbA1c < 7.5% or > 10% at baseline visit
  42. Any severe hypoglycemic event since the screening visit
  43. CGM readings <54 mg/dl in more than 1% of time by CGM since the screening visit
  44. CGM readings > 360 mg/dL in more than 1% of time
  45. Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic)
  46. Women of child-bearing potential with a positive urine pregnancy test at baseline visit
  47. LA Grade C or greater esophagitis on endoscopy
  48. Abnormalities of the GI tract preventing endoscopic access to the duodenum
  49. Anatomic abnormalities in the duodenum that would preclude the completion of the treatment procedure, including tortuous anatomy
  50. Endoscopic observation of upper gastrointestinal abnormality such as ulcers, polyps, varices, strictures, congenital or intestinal telangiectasia
  51. Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014204


Contacts
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Contact: Marie Steinbrink 651-329-0351 msteinbrink@endogenex.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Claudia Riveroll       claudia.riveroll@med.usc.edu   
Principal Investigator: John Lipham, MD         
United States, Minnesota
Cuyuna Regional Medical Center Not yet recruiting
Crosby, Minnesota, United States, 56441
Contact: Melissa Dyrdal, APRN-CNP       melissa.dyrdal@cuyunamed.org   
Principal Investigator: Howard McCollister, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Liz Lemke, MPH       Lemke.Elizabeth@mayo.edu   
Principal Investigator: Andrew Storm, MD         
Sponsors and Collaborators
DyaMX Inc.
Investigators
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Study Chair: Daniel DeMarco, MD Baylor Scott & White
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Responsible Party: DyaMX Inc.
ClinicalTrials.gov Identifier: NCT05014204    
Other Study ID Numbers: 346
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by DyaMX Inc.:
Endoscopy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases