Dapagliflozin/Sitagliptin - Film coated tablets
5mg+50mg, 10mg+50mg, 5mg +100mg, 10mg+100mg
Description:
The product delivers the two compounds systemically equivalent to Forxiga (Dapagliflozin)
and Januvia (Sitagliptin).
Indication:
Substitution indication for patient already treated with the free combination of Dapagliflozin and Sitagliptin.
Other FDC of SGLT2 and DPP4 inhibitors are already approved with the following indications in adults aged 18 years and older with
type 2 diabetes mellitus:
• to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of the FDC do not provide
adequate glycaemic control
• when already being treated with the free combination of the 2 monocomponents of the FDC
Relevant patient groups:
SGLT2 inhibitors reduce hyperglycemia increasing urinary glucose excretion independent of insulin secretion or action.
DPP4 inhibitors, improve glucose homeostasis by increasing insulin secretion & decreasing glucagon secretion in a glucose-
dependent manner.
Clinical studies demonstrated significant clinical benefit combining Dapagliflozin and Sitagliptin vs monotherapy in terms of HbA1c
levels, body weight & fasting plasma glucose levels.
These 2 drugs rarely cause common adverse such as weight gain & hypoglycemia and the combination could be effective & safe for
the treatment of hyperglycemia in patients with sub-optimally controlled type 2 diabetes.
Key selling point:
• Complementary mechanism of action for the control of type 2
diabetes
• No side effect such as hypoglycaemia or weight gain
• Potential reduction of heart failure and chronic kidney disease
• Better treatment compliance by reducing the pill burden
