Diabetes Mellitus, Type 2 Clinical Trial
Official title:
TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy
To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy
The present protocol will address whether the effects of the TANTALUS treatment are
complimentary to GLP-1 treatment which is only partially effective or whether it can replace
GLP-1 treatment in individuals who cannot tolerate GLP-1 agonists because of unacceptable
side effects.
This investigation will be a 3 arm multicenter study which will enroll in a Run-In Period up
to 400 with type 2 diabetes mellitus. This Run-In Period will facilitate screening the
patients with the aim to have a maximum of 30 patients in each arm complete the Evaluation
Period of 6 months. The study aims at evaluating the TANTALUS therapy compared to GLP-1
receptor agonist therapy by evaluating improvement in glycemic control and weight after 6
months of treatment in each of the 3 study groups, which are:
- Group A: subjects on GLP-1 receptor agonist therapy only
- Group B: subjects on GLP-1 receptor agonist therapy and TANTALUS therapy
- Group C: subjects on TANTALUS therapy only
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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