The RESET System Pivotal Clinical Trial (Protocol Revision K)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorMorphic Medical Inc.
About this trial
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study.
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥22 years and ≤ 65 years
Have understood and signed the approved informed consent form
Diagnosis of type 2 diabetes
HbA1c ≥ 7.5% and ≤10%
Disqualifiers
Previous treatment with the RESET System
Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance.
Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
Trial design
Design model
Parallel
Treatments tested in this trial
RESET Liner
DeviceThe RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
Sham
Other interventionPatient receives upper endoscopy but no treatment
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: RESET Treatment ArmExperimental treatment 1 intervention
Group B: Sham Control ArmSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c
Change in HbA1c value from baseline to 9 months.
Time frame
9 Months2
SAE Rate
Incidence of serious adverse events
Time frame
9 monthsSecondary outcomes
1
HbA1c Reduction
Proportion of patients who achieve an HbA1c reduction ≥0.5%
Time frame
9 and 21 months2
Weight Loss
Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
Time frame
9 and 21 months3
Insulin use
Reduction in percentage insulin units per day
Time frame
9 and 21 months4
Fasting blood glucose level
Reduction in fasting blood glucose values
Time frame
9 and 21 monthsOther outcomes
1
% HbA1c reduction
Proportion of patients who achieve an HbA1c reduction of ≥0.5%, ≥1%, ≥1.5% and ≥2%
Time frame
9 and 21 months2
Total Body Weight
Proportion of patients who achieve a % total body weight loss of ≥5%, ≥10%, and ≥15%
Time frame
9 and 21 months3
Insulin Units
Proportion of patients who achieve a reduction in total number of insulin units per day of ≥25%, ≥50%, ≥75% and ≥100%
Time frame
9 and 21 months4
HbA1c Value
Proportion of patients who achieve an HbA1c of \<7%
Time frame
9 and 21 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Morphic Medical Inc.
Lead sponsor
Biostatistical Consulting, Inc.
Collaborator
Source ClinicalTrials.gov