Digma System Study - Safety, efficacy and performance of the Digma system for the treatment of type 2 diabetes - sham control study

Phase 3

Suspended

• Conditions: diabetes type 2; 10018424

• Registration Number: NL-OMON52062
• Lead Sponsor: Digma Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified