Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy

Overview

About this study

The purpose of this study is to assess the effectiveness of Revita® DMR for improving HbA1c to ≤ 7% without the need of insulin in subjects with T2D compared to sham and to assess the effectiveness of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Male, and non-pregnant, non-lactating females

2. Age between 21 and 70 years (both inclusive)

3. Subjects with T2D on stable dose (up to maximally approved doses) of metformin and up
to 2 ADAs (including either GLP1 or DPP-4i and/or, TZD), requiring a minimum of 20
units up to a maximum of 60 units of basal insulin

4. Glycosylated hemoglobin A1c (HbA1c) of 7.5-9.5% (both inclusive) confirmed at the end
of at least 3 weeks stable run-in period

5. FPG ≥180 to <270 mg/dL (measured after overnight 8-hour fasting and 24-36 hours after
the last dose of glargine) at the end of at least 3 weeks stable run-in period

6. Body Mass Index (BMI) ≥ 24 to ≤ 40 kg/m2

7. Women of child-bearing potential (WOCBP) should have negative urine beta human
chorionic gonadotropin (hCG) pregnancy test and must agree to use two of the
established contraceptive methods throughout the study duration

8. Able to sign an informed consent form and comply with study requirements.

Exclusion Criteria:

1. Known case of absolute insulin deficiency as indicated by clinical assessment, and a
fasting plasma C-peptide of <0.6 ng/ml

2. Any drugs or concomitant medications (such as psychoactive drugs such as
carbamazepine, phenobarbital, sympathomimetics (ephedrine etc.), corticosteroids,
anabolic steroids, and male sex hormones such as testosterone, etc.) that can
interfere with glucose metabolism

3. Subjects who either are on SGLT2i, meglitinides, sulphonylurea (SUs), short or rapid
acting insulin or any other class of ADA other than permitted baseline ADAs at the
time of consent or who have a known or documented SGLT2i and/or metformin intolerance
prior to the study

4. Recurrent or severe urinary tract or genital mycotic infections or history of GU
infection within 4 weeks prior to informed consent

5. ALT >3 times upper limit normal values unless if associated with underlying NAFLD

6. Use of an investigational drug within 1 month or 5 half-lives (whichever is longer)
before the screening

7. Diagnosed with type 1 diabetes or with a recent history of ketoacidosis

8. Ketosis-prone T2D

9. History of non-healing diabetic ulcers or amputations

10. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months
of screening

11. In case of two or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear
correctable precipitating factor can be identified/clinically significant hypoglycemia
with self-monitored or laboratory plasma glucose level < 54 mg/dL (3.0 mmol/L / severe
hypoglycemic episode requiring third party assistance occurring during run-in period

12. Known intestinal autoimmune disease, as evidenced by either a positive anti-glutamic
acid decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of
lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder,
which affects the small intestine

13. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid
stimulating hormone (TSH) value outside the normal range at screening)

14. Known history of thyroid cancer or hyperthyroidism who have undergone treatment within
past 12 months or inadequately controlled hyperthyroidism

15. An uncontrolled endocrine condition such as multiple endocrine neoplasia etc. (except
T2D)

16. Known history of a structural or functional disorder of the esophagus, including any
swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal
reflux symptoms, active and uncontrolled Gastroesophageal Reflux Disease (GERD) (grade
3 esophagitis or greater)

17. Known history of a structural or functional disorder of the stomach, including gastric
ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or
type II and higher paraoesophageal hernia) cancer or any other disorder of the stomach

18. Previous GI surgery that could affect the ability to treat the duodenum such as
subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve or other
similar procedures or conditions

19. Known history of chronic pancreatitis or a recent history of acute pancreatitis within
the past year

20. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured)
or cirrhosis; or hepatic decompensation/acute liver disease during the last 6 months;
or alcoholic or autoimmune chronic hepatitis

21. Symptomatic gallstones or symptomatic kidney stones, acute cholecystitis

22. Clinically active systemic infection

23. 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), who are on potential immunosuppressants or whose immune
status makes the subject a poor candidate for clinical trial participation in the
opinion of the Investigator

24. History of active malignancy or partial remission from clinically significant
malignancy within the past 5 years (except basal or squamous cell skin cancer or
carcinoma in situ or those received curative treatment and in complete remission for 5
years or if subject confirmed as cancer free)

25. Known active coagulopathy, or current upper gastro-intestinal bleeding conditions such
as ulcers, gastric varices, strictures, or congenital or acquired intestinal
telangiectasia

26. Subjects with active helicobacter pylori infection (Subjects may be enrolled if they
had history of h pylori infection and were successfully treated)

27. Known cases of anemia, thalassemia or conditions that affect red blood cell (RBC)
turnover such as recent blood transfusion within 90 days

28. Use of anticoagulation therapy (such as warfarin, coumadin, novel oral anticoagulants
[NOAC]) or anti-platelet agents (such as thienopyridine) which cannot be discontinued
for 5-7 days or 2 drug half-lives before the procedure

29. Use of systemic glucocorticoids (excluding topical or ophthalmic application or
inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening
Visit

30. Use of drugs known to affect GI motility (e.g., metoclopramide)

31. History of moderate to severe chronic kidney disease (CKD), with estimated glomerular
filtration rate (eGFR) <45 mL/min/1.73m2 (estimated by Modification of Diet in Renal
Disease [MDRD]) or end stage renal failure or on dialysis

32. History of myocardial infarction, stroke, or major event requiring hospitalization
within the last 3 months prior to screening

33. History of new or worsening signs or symptoms of coronary heart disease (CHD) within
the last 3 months

34. Known case of severe peripheral vascular disease

35. Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class
II-IV) requiring pharmacologic therapy to control symptoms

36. Clinically significant electrocardiogram (ECG) findings such as new clinically
significant arrythmia or conduction disturbances that increases risk and requires
intervention as determined by the investigator

37. Subjects who are at risk for pancreatitis particularly those with a recent fasting
triglycerides value of > 600 mg/dL value done within past 3 months

38. Actively participating in a weight loss program and is currently not in the
maintenance phase

39. General contraindications to deep or conscious sedation or general anesthesia or high
risk as determined by anesthesiologist (e.g., ASA score 4 or higher) or
contraindications to upper GI Endoscopy

40. History of any illicit alcohol or substance abuse

41. Use of weight loss medication such as Meridia, Xenical, or over the counterweight loss
medications or other prescribed medications used specifically for purpose of weight
loss

42. Use of Dietary supplements or herbal preparations that may have unknown effects on
glycemic control, risk of bleeding

43. Participating in another ongoing clinical trial of an investigational drug or device

44. History of non-adherence to treatment in the previous 6 months, as determined by the
investigator based on patient history, HbA1c value and/or drug accountability

45. Any other mental or physical condition which, in the opinion of the investigator,
makes the subject a poor candidate for clinical trial participation

46. Unwilling or unable to perform SMBG, complete the subject glycemia diary, or comply
with study visits and other study procedures as required per protocol

47. Recovered from severe COVID-19 infection (requiring hospitalization) however still
have persistent long COVID-19 symptoms (i.e., they have not recovered for several
weeks or months since the start of symptoms that were suggestive of COVID-19,
irrespective if they are tested or not).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rahul Pannala, M.D.

Contact us for the latest status

Contact information:

Christine Walters CCRP

(480) 301-6821

Walters.Christine3@mayo.edu

More information

Publications

Publications are currently not available
.

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