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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001003-36-AT

Enrollment

Registered

2014-05-20

Start date

2014-07-25

Completion date

Unknown

Last updated

2016-05-30

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

Conditions

Diabetes type 2 not controlled by oral medication.

Interventions

Trade Name: Lipanthyl Product Name: Lipanthyl 160 mg (Fenofibrate) Pharmaceutical Form: Capsule INN or Proposed INN: Fenofibrate CAS Number: 49562-28-9 Current Sponsor code: 60-10 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female subjects 18 through 70 years of age • Body mass index > 30 and 120 and =65 years) no F.1.3.1 Number of subjects for this age range

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

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. Relationship between blood TG level and the GCM efficacy will be evaluated. The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Secondary Objective: Not Applicable;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for: 1. Low blood TG patients 2. High blood TG patients 3. High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy ;Timepoint(s) of evaluation of this end point: Baseline vs 12 month post implant	—

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. Relationship between blood TG level and the GCM efficacy will be evaluated. The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Secondary Objective: Not Applicable;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for: 1. Low blood TG patients 2. High blood TG patients 3. High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy ;Timepoint(s) of evaluation of this end point: Baseline vs 12 month post implant

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Trends in weight loss will be of a reduction in weight during treatment in 3 patient groups 2. Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups ;Timepoint(s) of evaluation of this end point: Baseline vs 12 month post implant	—

Countries

Austria

Contacts

Public ContactDr. Ricardo Aviv

Metacure Ltd

ricardoa@metacure.com

Outcome results

None listed

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