Type 2 DiabetesNCT02079376
The DIAMOND® for the Treatment of Type 2 Diabetes
A study testing DIAMOND System in people with Type 2 Diabetes, run by MetaCure Limited at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- DIAMOND System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Nov 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Poland5 sites, 5 recruiting
- Recruiting
Medical University
Bialystok
Maria Górska, MD, PhD, 48857468239
- Recruiting
Medical University
Bydgoszcz
Roman Junik, MD, PhD, 48525854020
- Recruiting
"Diabeta-Care"
Lubin
Irena Szykowna, MD, PhD, 48693729109
- Recruiting
Medical University
Szczecin
Syrenicz Anhelli, MD, PhD, 4860170884
- Recruiting
Centre for Postgraduate Medical Education (CMKP)
Warsaw
Wiesław Tarnowski, MD, PhD, +48602346242
Greece2 sites, 1 recruiting
- Active, not recruiting
"Attikon" Hospital
Athens
- Recruiting
"Evgenidio " Hospital
Athens
Nikolaos Arkadopoulos, Prof., 306937106217
Italy2 sites, 2 recruiting
- Recruiting
Clinica Pineta Grande
Rome
Dott. Cristiano Giardiello, MD, +39335406848
- Recruiting
The Università Cattolica del Sacro Cuore
Rome
Gertrude Mingrone, Prof., paolo.ferrazza@lnage.it
Serbia2 sites, 2 recruiting
- Recruiting
Klinika za digestivnu hirurgiju
Belgrade
Miloš BJELOVIĆ, Prof. dr, acerimanovic@hungarotrial.com
Miloš BJELOVIĆ, Prof. dr
- Recruiting
Institut za pluće bolesti Vojvodine
Kamenica
Miroslav ILIĆ, Prof. dr, acerimanovic@hungarotrial.com
Miroslav ILIĆ, Prof. dr
Australia1 site, 1 recruiting
- Recruiting
Epworth Research Institute
Richmond, Victoria
Spiros Fourlanos, MD, spiros.fourlanos@nh.org.au
About this study
Official 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
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
- Being tested
- DIAMOND System
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAMOND SystemDevice
DIAMOND Implantable Pulse Generator (IPG)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Device: DIAMOND System |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of HbA1c
improvement of glycemic control measured by changes in HbA1c
Measured: 48 weeks
Secondary outcomes (1)
Relationship between blood TG level and the GCM efficacy
Relationship between blood TG level and the GCM efficacy
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetaCure Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079376
- Sponsor's protocol ID
- MC CP TAN2012-60
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02079376
- Acronym / sponsor ID
- MC CP TAN2012-60
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- MetaCure LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low blood TG patients | Experimental | Device: DIAMOND Systemsubjects 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. |
| High blood TG patients treated with blood TG lowering therapy | Experimental | Device: DIAMOND Systemsubjects 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 |
| High blood TG patients | Placebo comparator | Device: DIAMOND Systemsubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIAMOND SystemDIAMOND Implantable Pulse Generator (IPG) | Device | High blood TG patients, High blood TG patients treated with blood TG lowering therapy, Low blood TG patients |
Primary outcome
improvement of HbA1c
Time frame: 48 weeks
improvement of glycemic control measured by changes in HbA1c
1 secondary outcome
Relationship between blood TG level and the GCM efficacy
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIAMOND System in people with Type 2 Diabetes, run by MetaCure Limited at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Greece, Italy, Serbia, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of HbA1c (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.