To evaluate the safety and performance of the Digma System for duodenal submucosal ablation in patients with type 2 diabetes in comparison to baseline and to sham control.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The incidence of type 2 diabetes is increasing in a rapid pace. Patients with
type 2 diabetes have a high risk of cardiovascular complications.
There are several types of pharmacological agents for the treatment of type 2
diabetes. They however, don't target the root cause of the disease. Moreover,
glucose control has not improved in patients with type 2 diabetes over the past
years.
Studies out of the field of bariatric surgery report that the duodenum plays an
important role in glucose homeostasis. It is hypothesized that the duodenal
mucosa changes in people with type 2 diabetes. The Revita System for duodenal
ablation has shown that was safe and effective in improving glycaemic control
and metabolic parameters in patients with type 2 diabetes.
This new Digma EGM procedure also elicits regeneration of the duodenal mucosa.
We want to investigate te safety, feasibility and effectiveness of this
procedure in patients with type 2 diabetes, on oral medication.
See section 1 of the protocol for more information.
Study objective
To evaluate the safety and performance of the Digma System for duodenal
submucosal ablation in patients with type 2 diabetes in comparison to baseline
and to sham control.
Study design
The study consists of 2 parts.
Study Part A is 24 weeks randomized, parallel assignment, double blinded study
Study Part B is a 24 weeks unblinded study
Study Part A:
Active comparator: Endoscopic Glycemic Management (EGM) Procedure
EGM Procedure will include the endoscopic procedure for the creation of
ablations in the submucosa layer in the duodenum.
Sham comparator: Sham Procedure (Sham)
Sham Procedure (Sham) will include the endoscopic procedure without the
creation of ablations in the submucosa layer in theduodenum.
Study Part B:
Active comparator: will be followed for an additional 24 weeks
Cross over: Sham comparator will now undergo EGM Procedure and will be followed
for 24 weeks
Intervention
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 (*Digma Catheter*).
Study burden and risks
The burden and risk mainly consist out of extra time spent in comparison to
standard treatment, the DMR or sham procedure andthe risks of
medical evaluation, including venapunctures and biopsy.
See the protocol, section 6 for more information on measure that were taken to
minimalize risks for study participants.
HaArava St. 1
Givat Shmuel 5400804
IL
HaArava St. 1
Givat Shmuel 5400804
IL
Listed location countries
Age
Inclusion criteria
1. Subjects who are >= 18 years and <= 75 years of age
2. Type 2 diabetes diagnosis with disease duration <=15 years
3. HbA1c at 8.0%-10.5%
4. Subjects, in the opinion of the investigator, who have been
unsuccessfully managed with lifestyle (diet/exercise) counselling
and are taking >= 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
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 <1 ng/ml
3. Fasting Triglycerides > 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 < 3.2 g/dL
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76710.018.21 |