The TANTALUS® II for the Treatment of Type 2 Diabetes (Crossover)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The TANTALUS® II for the Treatment of Type 2 Diabetes: A Single-Blind Cross-Over Study|
- Comparison of the differences in HbA1c levels [ Time Frame: One year ] [ Designated as safety issue: No ]Comparison of the differences in HbA1c levels between treatment and control groups between changes occurred during period 2 to period 3
- Improvement in weigth and metabolic parameters [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Trends in weight loss will be of a reduction in weight during periods 2 and 3.
- Trends in improvement in metabolic parameters such as waist circumference, blood pressure and lipids occurred during period 2 to period 3.
- Difference in device related Adverse Events between treatment and control groups between periods of active and inactive therapy.
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: GCM stimulation
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
The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes
Other Name: TANTALUS II
Sham Comparator: Device off
The TANTALUS System is implanted but is off
Device: TANTALUS system
The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes. In the sham comparator the device is off.
Other Name: TANTALUS II
This is a multi-center, single blind, randomized, cross-over study. Subject enrollment will continue until forty (40) eligible participants have been randomized into one of the two groups. Subjects will undergo baseline valuation (Visit 1) during which the stability of their glycemic parameters, medical treatment and medical condition will be assessed. Subjects meeting all inclusion/exclusion criteria at Visit 2 will be implanted. Approximately three days prior to their implantation, subjects will be seen for their 'pre-implant' medical evaluation (Visit 3). One week after implant (Visit 5, Week 1)subjects will be randomized into one of two groups (A and B).
"Group A" subjects will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for the first 24 week period (Period 1). At Visit 10, (week 25 and end of Period 1), Group A subjects will have their devices turned "OFF" for the next 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group A subjects will have their devices turned "On" for the next 24 weeks period (Period 3) "Group B" subjects will not have their device activated for the first 24 weeks (Period 1) of their study. At Visit 10 (week 25 end of Period 1), Group B subjects devices will have their device turned "ON" (i.e. activated to deliver CGM signals) for the 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group B subjects will have their devices turned "OFF" for the next 24 weeks period (Period 3).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303302
|Medical University of Vienna|
|Gemeinschaftspraxis Drs. Klausmann|
|Aschaffenburg, Germany, D-63739.|
|Arzt für Innere Medizin und Endokrinologie|
|Bad Nauheim, Germany|
|Frankfurt, Germany, 60594|
|Munster, Germany, 48153|
|Università Cattolica S. Cuore|
|Rome, Italy, 00168|
|CMKP- Centrum Medyczne Kształcenia Podyplomowego|
|Warszawa, Poland, 01-813|
|Study Director:||Walid Hadda, PhD||Metacure|