The DIAMOND® for the Treatment of Type 2 Diabetes

March 15, 2016 updated by: MetaCure Limited

The DIAMOND® for the Treatment of Type 2 Diabetes: Can Blood Triglycerides Level be the Predictor for Therapy Efficiency A Multicentre, Prospective, Semi-randomized Study

Study 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Richmond, Victoria, Australia
  • Austria
      • Innsbruck, Austria
        • Withdrawn
        • Tilak Innsbruck
  • Greece
      • AThens, Greece
        • Active, not recruiting
        • "Attikon" Hospital
      • Athens, Greece
        • Recruiting
        • "Evgenidio " Hospital
        • Contact:
          • Nikolaos Arkadopoulos, Prof.
          • Phone Number: 306937106217
  • Italy
      • Rome, Italy
        • Recruiting
        • Clinica Pineta Grande
        • Contact:
          • Dott. Cristiano Giardiello, MD
          • Phone Number: +39335406848
      • Rome, Italy
        • Recruiting
        • The Università Cattolica del Sacro Cuore
        • Contact:
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Medical University
        • Contact:
          • Maria Górska, MD, PhD
          • Phone Number: 48857468239
      • Bydgoszcz, Poland
        • Recruiting
        • Medical University
        • Contact:
          • Roman Junik, MD, PhD
          • Phone Number: 48525854020
      • Lubin, Poland
        • Recruiting
        • "Diabeta-Care"
        • Contact:
          • Irena Szykowna, MD, PhD
          • Phone Number: 48693729109
      • Szczecin, Poland
        • Recruiting
        • Medical University
        • Contact:
          • Syrenicz Anhelli, MD, PhD
          • Phone Number: 4860170884
      • Warsaw, Poland
        • Recruiting
        • Centre for Postgraduate Medical Education (CMKP)
        • Contact:
          • Wiesław Tarnowski, MD, PhD
          • Phone Number: +48602346242
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Klinika za digestivnu hirurgiju
        • Contact:
        • Principal Investigator:
          • Miloš BJELOVIĆ, Prof. dr
      • Kamenica, Serbia
        • Recruiting
        • Institut za pluće bolesti Vojvodine
        • Contact:
        • Principal Investigator:
          • Miroslav ILIĆ, Prof. dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects 18 through 70 years of age
  • Body mass index > 30 and < 45 (kg/m2)
  • Type 2 diabetes duration of at least 6 months
  • Type 2 diabetic subjects treated with oral anti-diabetic agents [Sulfonylurea, Metformin, thiazolinedione (TZD) or DPP-4 inhibitors]
  • Stable anti-diabetic medications for at least 3 months prior to enrollment, six months for thiazolinedione (TZD)
  • The subject has been under routine diabetes care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
  • HbA1c 7.3% and ≤ 9.5 % on Visit 1
  • Stable HbA1c, defined as no significant change (variation ≤ 0.5%) between a historical value recorded in the subject's medical record within 3 months prior to enrollment and the HbA1c gathered on Visit 1.
  • Fasting blood glucose >120 and < 350 mg/dl on Visit 1.
  • Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • Stable weight, defined as no significant weight change (variation <3%) within three months prior to enrollment as documented in the subject's medical record. For the subject treated with thiazolinedione, stable weight within six months.
  • If taking theses medication, sable anti-hypertensive and lipid-lowering medication for at least one month prior to enrollment
  • If subject is under anti-depressant medication the treatment needs to be stable for at least six months prior to enrollment.
  • Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the DIAMOND System
  • Willingness to perform at least four (3) capillary blood glucose tests per day twice a week for the duration of the study
  • Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
  • Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
  • Able to provide voluntary informed consent

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
  • Subjects with an EF less than 35% or otherwise indicated for an ICD
  • Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
  • Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
  • Prior wound healing problems due to staphylococcus or candida
  • Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
  • Use of anti-psychotic medications
  • Diagnosed with a eating disorder such as bulimia or binge eating
  • Obesity due to an endocrine disorder (e.g. Cushing disease)
  • Pregnant or lactating
  • Diagnosed with impaired liver function (liver enzymes 3 times greater than normal)
  • Any prior bariatric surgery
  • Any history of pancreatitis
  • Any history of peptic ulcer disease within 5 years of enrollment
  • Diagnosed with gastroparesis
  • Use of active medical devices (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
  • Cardiac history that physician feels should exclude the subject from the study.
  • Use of another investigator device or agent in the 30 days prior to enrollment
  • A history of life-threatening disease within 5 years of enrollment
  • Change in diabetic medication from between Visit 1 and Visit 3.
  • Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low blood TG patients
subjects with baseline blood triglyceride level ≤ 1.7 mmol/l will have intervention device (DIAMOND Implantable Pulse Generator (IPG)) programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period.
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)
EXPERIMENTAL: High blood TG patients treated with blood TG lowering therapy
subjects with baseline blood triglyceride level > 1.7 mmol/l will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period and will receive fenofibrate at the dose of 160mg per day
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)
PLACEBO_COMPARATOR: High blood TG patients
subjects with baseline blood triglyceride level > 1.7 mmol/l will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period and will receive placebo of fenofibrate administered in the same schedule as the drug.
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of HbA1c
Time Frame: 48 weeks
improvement of glycemic control measured by changes in HbA1c
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between blood TG level and the GCM efficacy
Time Frame: 48 weeks
Relationship between blood TG level and the GCM efficacy
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetaCure Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC CP TAN2012-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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