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

NCT01529216 | Completed

• 1 other identifier: MC CP TAN2011- 014
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

DIAMOND System; T2DM; Randomized study; Electrical stimulation; Fundus

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (5)

• HbA1c

  6 months

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

  6 and 12 months

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

  6 and 12 months

• Triglycerides

  Baseline

• HbA1c

  24 months

Study Arms (2)

Electrical signal ON

EXPERIMENTAL

Subjects randomized to this group (Group A) will receive electrical stimulation delivered to the fundus for 24 months.

Device: DIAMOND System

Sham

SHAM COMPARATOR

Subjects 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.

Device: DIAMOND System

Interventions

DIAMOND System DEVICE

Electrical stimulation to the fundus

Electrical signal ON; Sham

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MetaCure Limited: lead

Study Sites (2)

Hospital Georges Pompidou

Paris, France

Location

Atrium Medisch Centrum

Heerlen, Netherlands

Location

Related Links

• MetaCure

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan W.M. Greve, MD

  Atrium medisch centrum METC, Heerlen, The Netherlands

  PRINCIPAL INVESTIGATOR

• Chevallier, MD

  Hôpital GEORGES POMPIDOU 20 Rue Leblanc 75015 Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 8, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

FR (1); NL (1)