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Type 2 Diabetes MellitusRUBYNCT01529216

Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus

A study testing DIAMOND System in people with Type 2 Diabetes Mellitus, run by MetaCure Limited at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
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
2 participants
Where
2 sitesin 2 countries
Study dates
May 2012to Jan 2015
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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects 21 through 70 years of age
  • Body mass index ≥28 and ≤ 45 (kg/m2)
  • Type 2 diabetes duration more than 6 months and less than 10 years.
  • A baseline measurement (visit BL1) of HbA1c between ≥ 7.5% and ≤ 10.5%,
  • Type 2 diabetic subjects treated for at least 3 months with one or more maximum tolerable dosage of anti-diabetic agent (Any of the following: Sulfonylurea, Metformin, thiazolinedione (TZD), DPP-4 inhibitors).
  • Stable anti-hypertensive and lipid-lowering medication for at least one month prior to enrollment, if taken
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  • Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the System
  • 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

  • Injectable anti-diabetic therapy within the last 3 months (such as insulin and/or GLP-1 receptor agonists)
  • Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
  • Any gastric or upper GI surgery
  • Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
  • Prior wound healing problems
  • Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
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  • Use of anti-psychotic medications
  • Diagnosed with an eating disorder such as bulimia or binge eating
  • Obesity due to an endocrinopathy (e.g. Cushing disease, Hypothyroidism not treated)
  • Hiatal hernia requiring surgical repair or a paraesophageal hernia
  • 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 10 years of enrollment
  • Diagnosed with Gastroparesis or other GI motility disorder
  • 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 /surgeon feels should exclude the subject from the study.
  • Use of another investigational device or agent in the 30 days prior to enrollment
  • A history of life-threatening disease within 5 years of enrollment
  • 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

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Hospital Georges Pompidou

    Paris

Other trials in France

Netherlands1 site

  • Atrium Medisch Centrum

    Heerlen

Other trials in Netherlands

About this study

Official title: An Advanced Configuration (The Third Generation) of the DIAMOND System for the Treatment of T2DM Patients - A Randomized, Double Blind Study

The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.

The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.

Read the detailed description

The study protocol will also apply measures to better understand the mechanism of action of the effect.

Being tested
DIAMOND System
Keywords
DIAMOND System, T2DM, Randomized study, Electrical stimulation, Fundus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIAMOND SystemDevice

    Electrical stimulation to the fundus

Study groups in NCT01529216
Study groupRoleWhat they receive
Electrical signal ONExperimentalSubjects randomized to this group (Group A) will receive electrical stimulation delivered to the fundus for 24 months.
Receives: Device: DIAMOND System
ShamSham comparatorSubjects randomized to this group (Group B) will have their device in "turned off" mode for the first 12 months (48 weeks) after implant. Then the device will be turned ON and these subjects will receive therapy for the remaining 12 months of the study.
Receives: Device: DIAMOND System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    The primary end point will be the difference, at 12 months, in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System.

    Measured: 12 months

Secondary outcomes (5)

  1. HbA1c

    The difference, at 6 months in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System.

    Measured: 6 months

  2. GI hormones (C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin)

    To detect differences in the pattern of meal-related release of GI hormones (slope / area under the curve, etc)between the treatment and the control groups, as analyzed by repeated-measures ANOVA. Glucose, insulin and the following GI hormones will be measured prior and post meal consumption: C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin.

    Measured: 6 and 12 months

  3. Metabolic parameters (fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference)

    The difference in metabolic parameters at 6 and 12 months from baseline between the two arms. Including: fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference.

    Measured: 6 and 12 months

  4. Triglycerides

    The effect of the TG level at baseline on treatment efficacy

    Measured: Baseline

  5. HbA1c

    The change in HbA1c from baseline to 12 months and 24 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529216
Sponsor's protocol ID
MC CP TAN2011- 014
Acronym
RUBY
Status last verified
Mar 2016
First submitted
31 Jan 2012
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing DIAMOND System in people with Type 2 Diabetes Mellitus, run by MetaCure Limited at 2 sites in 2 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 10 inclusion and 21 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: finished, 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 2 sites in France, Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01529216.

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.

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