Evaluation of the Tantalus System in Type 2 Diabetic Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes; Obesity

• Registration Number: NCT00276471
• Lead Sponsor: MetaCure Limited

Brief Summary

Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2007-01
• Study Completion: 2007-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• T2DM subjects inadequately controlled on a maximum of three oral agents
• Subjects with HbA1c between 7 and 9%
• Subjects with FBG between 120 and 200 mg/dL
• Subjects who are 21-60 years old
• Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
• Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
• Subjects with waist circumference >94 cm (males) and >80 cm (females)
• Subjects on stable medication program for at least three months with any oral medication program
• Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
• Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
• Able to provide voluntary informed consent.

Exclusion Criteria

• Subjects at high risk of general anesthesia or surgery
• Subjects with prior pancreatitis
• Subjects with chronic hepatitis
• Subjects with elevated serum creatinine
• Subjects with proliferative diabetic retinopathy
• Subjects with gastroparesis or intestinal pseudo-obstruction
• Subjects with motility disorders of the GI tract
• Subjects who are receiving medications known to affect gastric motility
• Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
• Subjects who are pregnant (proven by positive hCG), or lactating
• Subjects who have had prior bariatric surgery
• Subjects with a history of peptic ulcer disease
• Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
• Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
• Subjects with a life-threatening co-morbidity or life expectancy of less than one year
• Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
• Subjects with a history of malignant disease
• Subjects who are currently on chemotherapy treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of blood chemistry, hematology and urinalysis
Ability to record electrical activity from the stomach
Evaluation of the of device and/or procedure related adverse events
Ability to communicate between patient wand and the device.

Secondary Outcome Measures

Name	Time	Method
Significant decrease in the HbA1c values between baseline and end-of-treatment
Reduction in the required medications due to improved glycemia.
Significant reduction in weight loss between baseline and end-of-treatment
Improvement in co-morbid parameters

Trial Locations

Locations (1)

Allgemeinen Krankenhauses der Stadt Wein AkH; 🇦🇹 Vienna, Austria