The TANTALUS® II for the Treatment of Type 2 Diabetes

NCT01303302 | Completed DMC

• 2 other identifiers: MC CP TAN2007-032Cross-over
• Study Type: interventional
• Target: 51
• Locations: 4 countries
• Sites: 7

Brief Summary

Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation using the TANTALUS System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated

Conditions

Diabetes Mellitus, Type 2

Keywords

C19 246 300

Outcome Measures

Primary Outcomes (1)

• Comparison of the differences in HbA1c levels

  Comparison of the differences in HbA1c levels between treatment and control groups between changes occurred during period 2 to period 3

  One year

Secondary Outcomes (1)

• Improvement in weigth and metabolic parameters

  One year

Study Arms (2)

GCM stimulation

ACTIVE COMPARATOR

The patient will be implanted with a gastric contractility modulation (GCM) stimulation system using the TANTALUS System for treatment of type 2 diabetic patients.

Device: Tantalus System

Device off

SHAM COMPARATOR

The TANTALUS System is implanted but is off

Device: TANTALUS system

Interventions

TANTALUS system DEVICE

The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes

Also known as: TANTALUS II

GCM stimulation

Eligibility Criteria

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

You may qualify if:

• Male and female subjects 18 through 70 years of age
• Body mass index \>=28 and \<=45 (kg/m2)
• Type 2 diabetes duration more than 6 month
• Type 2 diabetic sublecys treated with oral anti-diabetic agents
• Stable anti-diabetic medication for at least 3 month prior to enrollment
• HbA1c \>=7.5% and \<=9.5% on visit 1; subjects with T2DM duration .10 years should have \<=9.0% at visit 1
• Stable HbA1c, defined as no significant change (variation \<=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
• Fasting blood glucose \>120 and \< 240 mg/dl on visit 1; subjects with T2DM duration \> 10 yaers should have .120 ans\<=180 mg/dl at visit 1
• Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
• Stable weight, defined as no significant weight change (variation \<5%)within three months prior to enrollment
• If taking these medication, stable anti-hepertensive and lipid-lpwering medication for at least one month prior to enrollment
• If subject is under unti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
• Wllingness to refrain from using prescription, over the counter or herbal weight loss product for the duration of the trial
• Ability and willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II Syatem
• Alert, mentally competant, 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

You may not qualify if:

• Insulin therapy
• Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affec gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
• Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
• Experiencing sever and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
• Prior wound healing problems
• Diagnosed with past or present psychiatric condition that may impair his or her ability to comply with the study procedure
• Use of anti-pchichotic medication
• Diagnosed with an eating disorder such as bulimia or binge eating
• Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)
• Hiatal hernia requiring surgical repair or paraesophageal hernia
• Pregnant or lactating Diagnosed with impared liver function (liver enzyms 3 times graeted than normal)
• Any prior bariatric surgery
• Ant history of pancreattitis Any history of peptic ulcer disease within 5 years of enrollemnt Diagnosed with gastroparesis or GI mobility disorder Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn) Subject using an external active device who are able anf willing to avoid use of the device during the study may be enrolled.
• Cardiac history that physician feels should exclude the subject from the study.
• Use of anotherc investigational device agent in the 30 dayes prior to enrollemnt

Sponsors & Collaborators

• MetaCure (USA), Inc.: lead

Study Sites (7)

Medical University of Vienna

Vienna, Austria

Location

Gemeinschaftspraxis Drs. Klausmann

Aschaffenburg, D-63739., Germany

Location

Arzt für Innere Medizin und Endokrinologie

Bad Nauheim, Germany

Location

Krankenhaus Sachsenhausen

Frankfurt, 60594, Germany

Location

Diabetes-Praxis Muenster

Münster, 48153, Germany

Location

Università Cattolica S. Cuore

Rome, 00168, Italy

Location

CMKP- Centrum Medyczne Kształcenia Podyplomowego

Warsaw, 01-813, Poland

Location

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

• Walid Hadda, PhD

  MetaCure Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: April 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

AU (1); DE (4); IT (1); PL (1)