Diabetes Mellitus, Type II Clinical Trial
Official title:
Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes
In this study, the investigators will assess the efficacy and tolerability of a novel, initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2 diabetes.
ADA/EASD guideline recommends sequential treatment approach starting with metformin, and
adding other classes of anti-diabetic medications if target HbA1c is not achieved. However,
several clinical studies clearly showed that initial dual or triple combination therapy was
more favorable in terms of glycemic control.
A DPP-4 inhibitor saxagliptin increases serum level of GLP-1, and potentiates its action of
increasing glucose-dependent insulin secretion and lowering glucagon secretion. A SGLT-2
inhibitor dapagliflozin lowers hyperglycemia via blocking SGLT-2 to increase glucosuria,
that is, in an insulin-independent manner. Therefore, the mechanism of action of these drugs
are complimentary to that of metformin, and all of these have a low risk of hypoglycemia and
weight gain.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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