Trial Outcomes & Findings for Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes (NCT NCT03653091)

NCT ID: NCT03653091

Last Updated: 2024-02-14

Results Overview

Change in HbA1c from baseline in DMR vs Sham groups

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

24 weeks post procedure

Results posted on

2024-02-14

Participant Flow

All eligible subjects participated in a 4-week oral antidiabetic drug (OAD) run-in period before randomization to the index procedure to assess stability of blood glucose control in conjunction with medication compliance and lifestyle (diet, exercise) counseling. All subjects were managed according to the current diabetes standard of care.

Participant milestones

Participant milestones
Measure	Duodenal Mucosal Resurfacing Procedure (DMR) Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes. The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks.	Sham Procedure (Sham) Sham treatment (Sham) will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes. The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
First 24 Weeks STARTED	6	3
First 24 Weeks Intent-to-Treat	6	3
First 24 Weeks As-Treated	5	4
First 24 Weeks Safety	5	4
First 24 Weeks COMPLETED	6	3
First 24 Weeks NOT COMPLETED	0	0
Second 24 Weeks STARTED	5	4
Second 24 Weeks Crossed Over to DMR at Week 24	0	3
Second 24 Weeks COMPLETED	5	3
Second 24 Weeks NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duodenal Mucosal Resurfacing Procedure (DMR) n=5 Participants Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes. The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.	Sham Procedure (Sham) n=4 Participants Sham treatment (Sham) will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes. The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	57.0 years STANDARD_DEVIATION 3.83 • n=5 Participants	53.5 years STANDARD_DEVIATION 4.20 • n=7 Participants	56.0 years STANDARD_DEVIATION 3.93 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Height (cm)	171.44 cm STANDARD_DEVIATION 9.871 • n=5 Participants	176.03 cm STANDARD_DEVIATION 5.954 • n=7 Participants	173.48 cm STANDARD_DEVIATION 8.237 • n=5 Participants
Weight (kg)	92.24 kg STANDARD_DEVIATION 7.513 • n=5 Participants	94.4 kg STANDARD_DEVIATION 7.366 • n=7 Participants	93.2 kg STANDARD_DEVIATION 7.062 • n=5 Participants
Body mass index (kg/m^2)	31.50 kg/m^2 STANDARD_DEVIATION 2.630 • n=5 Participants	30.28 kg/m^2 STANDARD_DEVIATION 1.841 • n=7 Participants	30.96 kg/m^2 STANDARD_DEVIATION 2.268 • n=5 Participants
HbA1c (%)	8.3 mmol/mol STANDARD_DEVIATION .738 • n=5 Participants	8.73 mmol/mol STANDARD_DEVIATION .512 • n=7 Participants	8.49 mmol/mol STANDARD_DEVIATION .649 • n=5 Participants
Duration of T2D Diagnosis (days)	4222.6 Days STANDARD_DEVIATION 1442 • n=5 Participants	4933 Days STANDARD_DEVIATION 1703.53 • n=7 Participants	4538.3 Days STANDARD_DEVIATION 1506.03 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks post procedure

Population: The AT population is a subset of ITT subjects who received at least 1 ablation or underwent the randomized sham procedure.

Change in HbA1c from baseline in DMR vs Sham groups

Outcome measures

Outcome measures
Measure	Duodenal Mucosal Resurfacing (DMR) n=5 Participants Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes. Duodenal Mucosal Resurfacing (DMR): The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.	Duodenal Mucosal Resurfacing Sham (Sham) n=4 Participants Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes. Duodenal Mucosal Resurfacing Sham (Sham): The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.
Change in Hemoglobin A1c (HbA1c)	-0.33 mmol/mol Standard Deviation .252	-0.70 mmol/mol Standard Deviation .469

Adverse Events

Duodenal Mucosal Resurfacing Procedure (DMR)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham Procedure (Sham)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham Crossover

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sarah Hackett, Sr. Director of Clinical Operations

Fractyl Health, Inc.

Phone: (781) 902-8840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Duodenal Mucosal Resurfacing Procedure (DMR) n=5 participants at risk Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes. The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.	Sham Procedure (Sham) n=4 participants at risk Sham treatment (Sham) will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes. The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.	Sham Crossover n=3 participants at risk Subjects that were in sham arm until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
Gastrointestinal disorders Diarrhoea	60.0% 3/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	75.0% 3/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	66.7% 2/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Abdominal Distension	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	33.3% 1/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Abdominal Pain	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Abdominal Pain Upper	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Nausea	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	33.3% 1/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Nervous system disorders Headache	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Nervous system disorders Paraesthesia	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Nervous system disorders Presyncope	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	40.0% 2/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory Symptom	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
General disorders Pyrexia	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
General disorders Nodule	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Infections and infestations Nasopharyngitis	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Psychiatric disorders Mental Status Changes	20.0% 1/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Ear and labyrinth disorders Ear Pain	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Investigations Blood Glucose Increased	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/5 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	25.0% 1/4 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.	0.00% 0/3 • Adverse events were followed for up to a maximum of 56 weeks. Deaths and/or Adverse Events are reported using the Safety Population.