Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Metacure; MetaCure Limited
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Able to provide written informed consent

• Adult patients aged between 18 and 60 years (inclusive)

• Male or female of Chinese ethnicity

• Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years

• severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m

• HbA1c greater than or equals to 7.5% but less than 10% despite treated with maximum dose or maximally tolerated dose of 2 anti-diabetic drugs (OAD) with good drug compliance

Exclusion Criteria:

• On anti-obesity drugs

• On insulin treatment at the time of the recruitment

• On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment

• On any implantable device including cardiac pacing

• Anticipated to have MRI examinations

• Fasting C-peptide level less than 0.5g/L

• Renal impairment (defined as serum creatinine greater than 150mol/L and/or estimated glomerular filtration rate less than 60 mL/min/1.73m)

• Significant liver impairment (ALT more than 3 times upper limit of normal range)

• Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible

• Active infection

• Active and uncontrolled thyroid diseases

• Childbearing age female patients without reliable contraceptive methods

• Life expectancy less than 12 months

• Administration of another investigational drugs or procedures within 4 weeks before screening

• Any medical illness or condition as judged by the investigators as ineligible to participate the study

• Special population, e.g. prisoner, mentally disabled, investigators' student or employees