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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 Safety Endpoint [ Time Frame: 12 weeks post-procedure ]Portion of participants experiencing device- or procedure-related serious adverse events (SAE)
- Changes in HbA1c [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in HbA1c
- Changes in fasting plasma glucose [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in FPG
- Changes in insulin resistance [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in HOMA-IR
- Changes in post-prandial glucose [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes in PPG by mixed meal tolerance test
- Changes in Weight [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in weight
- Changes systolic and diastolic blood pressure [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in systolic and diastolic blood pressure
- Changes in alanine aminotransferase (ALT) [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in ALT
- Changes in aspartate aminotransferase (AST) [ Time Frame: 4, 12, 24, 36, 48 weeks ]Mean changes from baseline in AST
- Changes in glucose-lowering medication usage [ Time Frame: 4, 12, 24, 36, 48 weeks ]Changes in usage of glucose-lowering medications
- Procedural success [ Time Frame: At the time of procedure ]Percentage of participants with successful DMR procedure
- Procedural Time [ Time Frame: At the time of procedure ]Time between catheter insertion to catheter removal
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.
|Ages Eligible for Study:||22 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Women of childbearing potential must be using an acceptable method of contraception throughout the study
- Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
- Proof of COVID 19 vaccination.
- 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.
- Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
- History of, or gastrointestinal symptoms suggestive of gastroparesis.
- Acute gastrointestinal illness in the previous 7 days
- Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
- History of chronic or acute pancreatitis.
- Known active hepatitis or active liver disease other than NASH/NAFLD.
- Alcoholic liver disease, as indicated by ANI > 0
- Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
- Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
- 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.
- 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.
- Use of drugs known to affect GI motility (e.g. Metoclopramide)
- Use of weight loss medications such as Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication)
- 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.
- Persistent anemia, defined as hemoglobin <10 g/dL.
- Known history of hemoglobinopathy.
- Known history of blood donation or transfusion within 3 months prior to the Screening Visit.
- Known history of cardiac arrythmia
- 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.
- Estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73m2 (estimated by MDRD).
- 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.
- History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening)
- With any implanted electronic devices or duodenal metallic implants
- Not a candidate for upper GI endoscopy or general anesthesia.
- Active illicit substance abuse or alcoholism (>2 drinks/day regularly)
- Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
- Women breastfeeding
- Participating in another ongoing clinical trial of an investigational drug or device.
- Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
Critically ill or has a life expectancy <3 years
Additional exclusion criteria to be confirmed during the screening process:
- HbA1c < 7.5% or > 10% at baseline visit
- Any severe hypoglycemic event since the screening visit
- CGM readings <54 mg/dl in more than 1% of time by CGM since the screening visit
- CGM readings > 360 mg/dL in more than 1% of time
- Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic)
- Women of child-bearing potential with a positive urine pregnancy test at baseline visit
- LA Grade C or greater esophagitis on endoscopy
- Abnormalities of the GI tract preventing endoscopic access to the duodenum
- Anatomic abnormalities in the duodenum that would preclude the completion of the treatment procedure, including tortuous anatomy
- Endoscopic observation of upper gastrointestinal abnormality such as ulcers, polyps, varices, strictures, congenital or intestinal telangiectasia
- Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure
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
|Contact: Marie Steinbrinkfirstname.lastname@example.org|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Claudia Riveroll email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Howard McCollister, MD|
|Rochester, Minnesota, United States, 55905|
|Contact: Liz Lemke, MPH Lemke.Elizabeth@mayo.edu|
|Principal Investigator: Andrew Storm, MD|
|Study Chair:||Daniel DeMarco, MD||Baylor Scott & White|
|Responsible Party:||DyaMX Inc.|
|Other Study ID Numbers:||
|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|
|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|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases