Clinical trial NCT03390322: Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients
Official title: DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Digma Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication.

Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.

Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.

Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of procedure related SAEs.
timeFrame: 7 days
measure: Incidence of procedure related SAEs.
timeFrame: 6 months
Secondary outcomes:
measure: Change to Fasting Glucose levels
timeFrame: 12 months
measure: Change to Post Prandial Glucose levels
timeFrame: 12 months
measure: Change to HbA1c levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: IKEM
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaarei Tzedek
Study officials:
References:
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.
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.
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.
citation: 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.