Health TrialsbyHealthPanel

Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

ConditionsType 2 Diabetes MellitusType2diabetesDiabetes Mellitus, Type 2DiabetesType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorEndogenex, Inc.

About this trial

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

22- 70 years of age, inclusive.

T2D diagnosis for at least 6 months.

HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.

BMI 27-40 kg/m2, inclusive.

Disqualifiers

Diagnosed with type 1 diabetes.

History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

Fasting serum C-peptide <1 ng/mL (333pmol/l).

Current use of insulin, or previous use of any types of insulin for >1 month at any time (except for treatment of gestational diabetes) in last 2 years.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ReCET Treatment

    Device

    Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum. Participants will be followed for 12 months post procedure.

  • Sham Procedure

    Device

    The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: ReCET ArmExperimental treatment 1 intervention
Group B: Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Change in HbA1c (%) from baseline to Month 6

Time frame
6 months post-procedure

Secondary outcomes

1

HbA1c

Change in HbA1c (%) from baseline to Month 12

Time frame
12 months post-procedure
2

HbA1c ≤7.0% without requiring rescue medication

Proportion of participants with HbA1c ≤7.0% without requiring rescue medication

Time frame
6 months post-procedure
3

Time-in Range (TIR)

Proportion of participants with TIR ≥70%

Time frame
6 months post-procedure
4

Total body weight loss (%TBWL)

Percent total body weight loss (%TBWL) from baseline to Month 6

Time frame
6 months post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endogenex, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now