diabetes T2DM
Conditions
Interventions
Gastric pacing with the DIAMOND System
Sponsors
MetaCure Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 enrolment, if taken ;Women with childbearing potential (i.e. not postmenopausal 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 trail, and personally motivated to abide by the requirements and restrictions of the clinical trail;Able to provide voluntary informed consent
Exclusion criteria
Exclusion criteria: Injectable anti-diabetic therapy within the last 3 months (such as insulin and/or GLP-1 receptor agonists);Taking medications known to effect 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 of 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 timer greater than normal);Any prior bariatric surgery;Any history of pancreatitis;Any history of peptic ulcer disease within 10 years of enrolment;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 enrolment;A history of life-threatening disease within 5 years of enrolment ;Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject form completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference, at 12 months, in HbA1c change from baseline, in patients with an active DIAMOND System. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HbA1c reduction in 6 months from baseline for patients with an active operating DIAMOND System 2. To detect differences in the pattern of meal related release of GI hormones. 3. The difference in metabolic parameters at 6 and 12 months from baseline between two arms. 4. The effect of TG level at basline on treatment effeicacy 5. The change in HbA1c from baseline to 12 months and 24 months | — |
Countries
Netherlands
Outcome results
None listed