drugset / Trial / NCT00975533

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

NCT00975533

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-10
Primary completion
2011-07
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic