The DIAMOND® for the Treatment of Type 2 Diabetes

NCT02079376 | Unknown

• 1 other identifier: MC CP TAN2012-60
• Study Type: interventional
• Target: 45
• Locations: 5 countries
• Sites: 12

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• improvement of HbA1c

  improvement of glycemic control measured by changes in HbA1c

  48 weeks

Secondary Outcomes (1)

• Relationship between blood TG level and the GCM efficacy

  48 weeks

Study Arms (3)

Low blood TG patients

EXPERIMENTAL

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

High blood TG patients treated with blood TG lowering therapy

EXPERIMENTAL

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

High blood TG patients

PLACEBO COMPARATOR

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

Interventions

DIAMOND System DEVICE

DIAMOND Implantable Pulse Generator (IPG)

High blood TG patients; High blood TG patients treated with blood TG lowering therapy; Low blood TG patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetaCure Limited: lead

Study Sites (13)

Epworth Research Institute

Richmond, Victoria, Australia

RECRUITING

Tilak Innsbruck

Innsbruck, Austria

WITHDRAWN

"Attikon" Hospital

Athens, Greece

ACTIVE NOT RECRUITING

"Evgenidio " Hospital

Athens, Greece

RECRUITING

Clinica Pineta Grande

Rome, Italy

RECRUITING

The Università Cattolica del Sacro Cuore

Rome, Italy

RECRUITING

Medical University

Bialystok, Poland

RECRUITING

Medical University

Bydgoszcz, Poland

RECRUITING

"Diabeta-Care"

Lubin, Poland

RECRUITING

Medical University

Szczecin, Poland

RECRUITING

Centre for Postgraduate Medical Education (CMKP)

Warsaw, Poland

RECRUITING

Klinika za digestivnu hirurgiju

Belgrade, Serbia

RECRUITING

Institut za pluće bolesti Vojvodine

Kamenica, Serbia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

SE (2); IT (2); AU (1); GR (2); PL (5)