New indication timely gift for type 2 diabetes patients

MANILA, Philippines - With the many sumptuous feasts and gastronomic temptations it brings, the Christmas season is often a dilemma for patients with diabetes trying to keep their blood sugar level in check.

Fortunately, this Christmas also brings good tidings: AstraZeneca’s oral anti-diabetic drug, saxagliptin, has been approved by the Philippine Food and Drug Administration (FDA) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar control in adult patients with type 2 diabetes.

The FDA approval was based on new Phase 3b data, which showed that saxagliptin 5 mg added to insulin (with or without metformin) significantly reduced blood sugar levels at 24 weeks and maintained these reductions over 52 weeks.

This latest approval broadens the therapeutic indications of saxagliptin. 

As monotherapy, saxagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

It is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.

As add-on combination, saxagliptin is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione, a sulfonylurea, or insulin (with or without metformin) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.

“The new data on saxagliptin in combination with insulin and the subsequent regulatory approval is certainly welcome news for doctors and patients. Since many patients with type 2 diabetes may eventually require insulin, it is important that oral anti-diabetic treatments can be safely and effectively used in combination with insulin to help patients reach their treatment goals,” said Dr. Chinnie Tan, medical director of AstraZeneca Philippines.

“This latest approval reinforces saxagliptin as a leading therapy to help people with type 2 diabetes better manage the disease,” said Amal Kelshikar, president of AstraZeneca Philippines.

Novel mode of action

Launched in the Philippines last July 2010, saxagliptin belongs to a novel class of oral anti-diabetes drugs called DPP-4 inhibitors.

DPP-4 is an enzyme that negatively affects blood sugar control by inactivating natural hormones in the body called incretin.

Incretins decrease elevated blood sugar (glucose) by increasing the body’s utilization of sugar, mainly by increasing insulin production in the pancreas and reducing the liver’s production of glucose. 

Clinical studies show that saxagliptin, either as monotherapy or combined with other commonly used oral anti-diabetes drugs, consistently produced clinically relevant and statistically significant reductions in all three key measures of glucose control known as the “glucose triad”: HbA1C, fasting plasma glucose, and post-prandial glucose. 

Sustained efficacy

Results of a new randomized clinical trial show that saxagliptin provides sustained efficacy (reduction in HbA1C) and good tolerability for patients with type 2 diabetes and moderate or severe renal impairment.

The presence of renal impairment, whether it occurs as an independent condition in diabetic patients or as a complication of the disease, makes diabetes treatment more complex and difficult.

The study’s findings suggest that saxagliptin can address an unmet need in patients with type 2 diabetes who have moderate or severe renal impairment.