diabetes type 2
Conditions
Interventions
Digma System is a laser based endoscopic device for the ablation of the
duodenal submucosa. The device is composed of two (2) components: 1)
laser generator unit, 2) a disposable endoscopic catheter
Sponsors
Digma Medical Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who are >= 18 years and = two anti-diabetes medication (orals or injectable GLP-1), other than insulin, at >= half the maximum recommended dose or at the maximally tolerated dose for at least 3 months 5. Fasting plasma glucose level at >=125 mg/dL 6. BMI 25-35 kg/m2 7. Negative pregnancy or nursing status and agreement to use of contraceptives during participation for women with childbearing potential 8. Ability to provide written informed consent 9. Willing and able to comply with follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes diagnosis and/or history of diabetic ketoacidosis and/or glutamic acid decarboxylase autoantibodies test (GAD Ab+) positive 2. Fasting Serum C peptide 400 mg/dL 4. Currently using or having used Insulin in the past (other than for hospitalization or acute illness) 5. Currently using Amylin analogs Hepatic and Gastrointestinal: 6. History of, or currently symptomatic for, pancreatitis, gallbladder/gallstones pathologies 7. Any known hepatic abnormality other than non-alcoholic fatty liver abnormality 8. Alcohol consumption >30 gram/day )2 glasses of beer or wine/day) 9. AST >5x upper limit of normal (ULN) and/or ALT >5x ULN 10. Serum albumin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety endpoint • Incidence of procedure related SAEs and AEs within 7 days post procedure. Primary Efficacy Endpoint: Primary efficacy endpoint at 24 weeks. • Change in HbA1c level compared with baseline • Change in HbA1c level compared with sham control | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety endpoints * Incidence of procedure related SAEs and AEs 4 weeks, 12 weeks and 24 weeks post procedure. Change in glycaemic, metabolic, hepatic and cardiovascular parameters, compared with baseline and sham control | — |
Countries
Netherlands
Outcome results
None listed