Overweight, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes, Overweight, Obese
Brief summary
The main purpose of this research study is to investigate whether the TANTALUS II System is effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes (high blood sugar) and are overweight. The research will also evaluate the impact on weight loss and will study other health conditions related to obesity. This research study involves an experimental system. The experimental system is the TANTALUS System, which consists of the implantable portion that includes the implantable pulse generator (IPG) and three pairs of implantable leads. There are also three external parts (items that are used outside your body): the programmer, the charger, and the Patient Wand.
Detailed description
This is a randomized, double-blind and controlled, multi-center study. Three hundred (300) subjects with type 2 diabetes ranging from low BMI to BMI 45 (BMI ≥ 28 and ≤ 45) will be enrolled. The duration of subject participation in the main portion of the study which includes the initial study and study extension periods is expected to be approximately 12 months. Upon completion of this period, subjects with a TANTALUS device shall continue to be followed clinically at six-month intervals (Safety Monitoring Period) until the FDA has made a determination regarding the safety and efficacy of the device.
Interventions
DEVICETANTALUS(TM) System
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the Treatment Group or Control Group after surgery at Week 1, Visit 5 (device activation).
Sponsors
MetaCure (USA), Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2) 2. Type 2 diabetes \>6 months 3. Type 2 diabetic subjects treated with oral anti-diabetic 4. Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD 5. HbA1c ≥7.5% and ≤ 9.5 % at Visit 1, subjects with T2DM duration \> 10 yrs should have HbA1c ≥7.5% and ≤ 9.0 6. Stable HbA1c, Stable weight, and stable treatment with anti-hypertensive and/or lipids lowering medications 7. Fasting blood glucose \>120 and \< 240 mg/dl at Visit 1, subjects with T2DM duration \> 10 yrs should be \>120 and ≤180. 8. Women with childbearing potential must agree to use adequate birth control methods 9. Stable weight - no significant change (variation \< 5%) in the last 6 months 10. Willingness to perform at least 4 capillary blood glucose tests per day twice a week for the duration of the study 11. Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial 12. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System 13. Alert, mentally competent, 14. Able to provide voluntary informed consent and HIPAA Authorization
Exclusion criteria
1. Receiving insulin therapy 2. Taking GLP-1, Amylin treatment (Byetta, Symlin) 3. Blood pressure levels of \>180/100 4. Patients with an EF less than 35% (obtained within last 6 months) or indicated for an ICD; if echocardiogram outdated or unavailable, procedure to be done 5. Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics 6. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the two months prior to enrollment 7. Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria) 8. Prior wound healing problems due to Staphylococcus and Candida 9. Prior bariatric surgery 10. History of pancreatitis 11. History of peptic ulcer disease within 5 years of enrollment 12. Diagnosed with gastroparesis 13. Use of active medical devices (either implantable or external) such as ICD, pacemaker, 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. 14. Cardiac history that physician feels should exclude the patient 15. Use of another investigational device or agent in the 30 days prior to enrollment 16. A history of life-threatening disease within 5 years of enrollment 17. Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control as measured by HbA1c: Difference in mean reduction between Control and Treatment Groups will be evaluated. | At the end of the Initial Study Period |
Secondary
| Measure | Time frame |
|---|---|
| Device/procedure-related adverse events;hypoglycemic events; Proportion of subjects with HbA1c less than 7.0;reduction of weight for both groups;improvement of glycemic control as measured by HbA1c | The end of the Initial Study Period |
Countries
United States
Outcome results
None listed