DIAMOND device to evaluate the blood Triglycerides level level in patients with type 2 diabetes.

The DIAMOND® for the Treatment of Type 2 Diabetes: Can blood Triglycerides level be the predictor for therapy efficiency? - DIAMOND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001003-36-IT

Enrollment

Registered

2021-01-21

Start date

2016-02-05

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 2 MedDRA version: 21.0 Level: LLT Classification code 10012659 Term: Diabetic control impaired System Organ Class: 100000004861

Interventions

Trade Name: FULCROSUPRA 160 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FENOFIBRATO CAS Number: 49562-28-9 Current Sponsor code: 60-10 Other descriptive name: fenofibrate Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects 18 through 70 years of age, overweight and obese, Type 2 diabetes, with a body mass index (BMI) of 30 to 45 (kg/m2) and poor glycemic control defined as HbA1c = 7.3% and = 9.5% and fasting blood glucose (FBG) between 120-350 mg/dL. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: Insulin therapy in last 3 months; Taking GLP-1 agonists or in the last 3 months before the enrollment; Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment; any condition(s) for which it is contraindicated the possible intake of fenofibrate.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objectives of this study are to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c and the relationship between blood TG level and the GCM efficacy.;Secondary Objective: The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for: - Low blood TG patients; - High blood TG patients; - High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy.;Timepoint(s) of evaluation of this end point: 13 months	—

Measure

Time frame

Main Objective: The main objectives of this study are to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c and the relationship between blood TG level and the GCM efficacy.;Secondary Objective: The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for: - Low blood TG patients; - High blood TG patients; - High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy.;Timepoint(s) of evaluation of this end point: 13 months

—

Secondary

Measure	Time frame
Secondary end point(s): Trends in weight loss will be of a reduction in weight during treatment in 3 patient groups; Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups; Trends in improvement in metabolic parameters such as waist circumference, blood pressure and lipids 3 patient groups.;Timepoint(s) of evaluation of this end point: 13 months	—

Countries

Australia, Austria, Greece, Italy, Poland, Serbia

Contacts

Public ContactCRO

L.N.Age srl

paolo.ferrazza@lnage.it0639746749

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026