Diabetes Mellitus, Type 2 Clinical Trial
Official title:
DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
| NCT number | NCT03390322 |
| Other study ID # | CLD-008 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 28, 2017 |
| Est. completion date | March 2025 |
This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.
| Status | Recruiting |
| Enrollment | 16 |
| Est. completion date | March 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Subjects who are = 18 years and = 75 years of age. - HbA1c at 7.5%-12% - On oral glucose lowering drugs in a stable medication regimen - Fasting plasma glucose level at =125mg/dL - BMI 25-40 Kg/m2 Exclusion Criteria: - Diagnosed Type I diabetes - Serum C peptide <1ng/ml |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | IKEM | Prague | |
| Israel | Soroka Medical Center | Beer Sheva | |
| Israel | Shaarei Tzedek | Jerusalem | |
| Spain | Barcelona Clinical Hospital | Barcelona | |
| Spain | Ramón y Cajal Insitute of Health Research | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Digma Medical Ltd. |
Czechia, Israel, Spain,
de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3. — View Citation
Ferrannini E, Mingrone G. Impact of different bariatric surgical procedures on insulin action and beta-cell function in type 2 diabetes. Diabetes Care. 2009 Mar;32(3):514-20. doi: 10.2337/dc08-1762. No abstract available. — View Citation
Mingrone G, Castagneto-Gissey L. Mechanisms of early improvement/resolution of type 2 diabetes after bariatric surgery. Diabetes Metab. 2009 Dec;35(6 Pt 2):518-23. doi: 10.1016/S1262-3636(09)73459-7. — View Citation
Salinari S, Bertuzzi A, Guidone C, Previti E, Rubino F, Mingrone G. Insulin sensitivity and secretion changes after gastric bypass in normotolerant and diabetic obese subjects. Ann Surg. 2013 Mar;257(3):462-8. doi: 10.1097/SLA.0b013e318269cf5c. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of procedure related SAEs. | 7 days | ||
| Primary | Incidence of procedure related SAEs. | 6 months | ||
| Secondary | Change to Fasting Glucose levels | 12 months | ||
| Secondary | Change to Post Prandial Glucose levels | 12 months | ||
| Secondary | Change to HbA1c levels | 12 months |
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