Suspended

TANTALUS® II System for Type 2 Diabetes Treatment in Patients with BMI 28 to 45

Study Aim

This study aims to evaluate the effectiveness of the TANTALUS® II System in improving glycemic control, as measured by HbA1c, in type 2 diabetes patients with a Body Mass Index (BMI) between 28 and 45.

What is being tested

TANTALUS(TM) System

Device

Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 70 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: September 2007

See protocol details

Summary

Principal SponsorMetaCure (USA), Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleThe TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

NCT00547482

Principal SponsorMetaCure (USA), Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

14 inclusion criteria required to participate

Body mass index (BMI) ≥ 28 and ≤ 45 (kg/m2)

Type 2 diabetes >6 months

Type 2 diabetic subjects treated with oral anti-diabetic

Stable anti-diabetic medications ≥3 months prior to enrollment, six months for TZD

Show More Criteria

17 exclusion criteria prevent from participating

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.

Cardiac history that physician feels should exclude the patient

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Sham

They will all be implanted but not activated for the Initial Study Period (24 weeks), followed by all subjects assigned to treatment (Control Group with device activation) in the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.

Group II

Active Comparator

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). They will be followed for the Initial Study Period (24 weeks), followed by the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Scripps Clinic Del Mar

La Jolla / San Diego, United StatesOpen Scripps Clinic Del Mar in Google Maps

Suspended

Cedars Sinai

Los Angeles, United States

Suspended

University of Colorado at Denver Health Sciences Center

Denver, United States

Suspended

Washington University School of Medicine in St. Louis

St Louis, United States

Suspended10 Study Centers