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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02079376




Registration number
NCT02079376
Ethics application status
Date submitted
26/02/2014
Date registered
5/03/2014
Date last updated
16/03/2016

Titles & IDs
Public title
The DIAMOND® for the Treatment of Type 2 Diabetes
Scientific title
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
Secondary ID [1] 0 0
MC CP TAN2012-60
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - DIAMOND System

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.

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

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.


Treatment: Devices: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
improvement of HbA1c - improvement of glycemic control measured by changes in HbA1c
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Relationship between blood TG level and the GCM efficacy - Relationship between blood TG level and the GCM efficacy
Timepoint [1] 0 0
48 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Research Institute - Richmond, Victoria
Recruitment postcode(s) [1] 0 0
- Richmond, Victoria
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Greece
State/province [2] 0 0
AThens
Country [3] 0 0
Greece
State/province [3] 0 0
Athens
Country [4] 0 0
Italy
State/province [4] 0 0
Rome
Country [5] 0 0
Poland
State/province [5] 0 0
Bialystok
Country [6] 0 0
Poland
State/province [6] 0 0
Bydgoszcz
Country [7] 0 0
Poland
State/province [7] 0 0
Lubin
Country [8] 0 0
Poland
State/province [8] 0 0
Szczecin
Country [9] 0 0
Poland
State/province [9] 0 0
Warsaw
Country [10] 0 0
Serbia
State/province [10] 0 0
Belgrade
Country [11] 0 0
Serbia
State/province [11] 0 0
Kamenica

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Metacure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02079376
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02079376