AstraZeneca Pharma India Limited (AstraZeneca India) has announced the launch of its innovative anti-diabetic combination once-daily therapy Xigduo® XR for treatment of adults with type 2 diabetes.
Xigduo® XR is a product of AstraZeneca Group and is approved in 61 countries to date including US, EU & Japan. It combines two anti-diabetic agents with complementary mechanisms of action, the widely recommended first-line monotherapy (metformin) with a clinically trusted dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), in a once-daily oral tablet. This combination backed by the XR (extended release) technology provides 24-hour sugar control offering physicians and patients a new approach to the early achievement of treatment goals.
XIGDUO® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
SGLT2 inhibitors are a relatively new class of medicines that provide comprehensive control through HbA1c reduction, blood pressure control and weight reduction along with clinically proven better cardiovascular outcomes. Earlier in 2015, AstraZeneca India had launched the first CDSCO approved SGLT2 inhibitor in India under the brand name Forxiga® (dapagliflozin).
Commenting on the launch, Mr. Gagan Singh Bedi, Managing Director, AstraZeneca Pharma India Limited said, “Over 74 million patients are affected by diabetes today and a significant number do not reach their treatment goals. We believe this novel once-daily combination therapy of dapagliflozin and metformin can address an unmet medical need by offering a comprehensive and convenient treatment option for the Indian phenotype patient predisposed to comorbidities such as blood pressure and weight gain. Xigduo® XR is an exciting new addition to our diabetes portfolio and signifies our commitment to improving diabetes care through innovative treatment solutions”
Eight in ten Indians display a characteristic feature of the Indian Phenotype (greater degree of central body obesity, higher insulin resistance, and characteristic dyslipidemia) making them highly vulnerable to developing the nexus of type 2 diabetes, obesity, and hypertension. The clinical evidence further reveals that Indian diabetic patients have comorbidities such as hypertension and abdominal obesity and are at two-fold risk of cardiovascular and 40-70% increased the risk of renal complications. Xigduo® XR’s unique mode of action offers an alternate treatment solution that caters to these complications in Indian diabetic patients.
Dr. Anilda Dsouza, Head Medical Affairs, AstraZeneca India said, “Type 2 diabetes is a progressive disease and we are pleased to bring this innovative treatment option for physicians and patients that combines two trusted agents to help intensify the treatment right from the start and has the potential to delay the disease progression”
Substantial delays in treatment intensification in patients with type 2 diabetes is an important barrier to optimal patient outcomes. XIGDUO® XR acts to significantly lower A1C levels by reducing circulating blood sugar, decreasing the amount of glycated hemoglobin in the body. XIGDUO® XR does this through its multi-level action: its metformin component improves insulin sensitivity, increases peripheral glucose uptake and utilization, and reduces glucose production by the liver and its absorption by the intestine; and its dapagliflozin component prevents the kidneys from reabsorbing glucose and helps increase glucose excretion.
XIGDUO® XR is available in multiple dosage strengths of dapagliflozin and metformin HCl extended-release including 10/500 mg and 10/1000 mg and the starting dose can be individualized based on each patient’s current treatment regimen. It is not recommended for patients with type 1 diabetes mellitus or diabetic ketoacidosis.
Xigduo® XR joins the family of SGLT2i brands (Forxiga) in AstraZeneca’s strong diabetes portfolio. AstraZeneca offers products in three novel and fast-growing classes of diabetes treatments: DPP4, SGLT-2, and GLP-1. AstraZeneca India has two patented brands-Onglyza® (Saxagliptin) and Kombiglyze™ XR in the DPP4i segment, Bydureon in the GLP1 Analog treatment segment and FORXIGA® & XIGDUO® XR in the SGLT2i segment.
 G. Reach et al. Diabetes & Metabolism 43 (2017) 501–511