In a nutshell
This study examined the effects of adding dapagliflozin (Farxiga) in patients with uncontrolled type 2 diabetes despite taking metformin (Glucophage) plus a sulfonylurea (such as Amaryl or Glucotrol).
Some background
Metformin increases the body’s sensitivity to insulin, and is generally the first medication used in the treatment of type 2 diabetes. However, type 2 diabetes is a progressive disease and one treatment is often not enough. Sulfonylureas increase insulin production, and are often added on to metformin therapy. If this combination does not lead to blood glucose (sugar) control, other treatments must be added.
A third treatment option for patients are sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin. SGLT2 inhibitors lower blood glucose levels by increasing the amount of glucose removed from the body through urine. Dapagliflozin may benefit patients whose blood glucose is not controlled with both metformin and a sulfonylurea, but it is not known whether this combination is safe and effective.
Methods & findings
This study included 219 patients who were randomly assigned to receive either dapagliflozin or a placebo (a substance with no effect on the body used as a comparison), along with metformin and a sulfonylurea. HbA1c levels (an average measure of blood glucose over 3 months) were measured at the start of the study (baseline) and after 24 weeks of treatment.
HbA1c levels were significantly lower in the patients receiving dapagliflozin (a decrease of 0.86%) compared to the placebo group (a decrease of 0.17%). Decreases were higher in patients with higher baseline HbA1c levels. Patients with baseline HbA1c levels over 9% saw a decrease of 0.82%, while patients with baseline HbA1c levels less than 8% saw a decrease of 0.36%. 31.8% of patients receiving dapagliflozin achieved HbA1c levels less than 7% after 24 weeks, compared to 11.1% of patients receiving placebo.
48.6% of patients receiving dapagliflozin and 51.4% of patients receiving placebo experienced an adverse event (negative side effect) during treatment. A significantly higher number of dapagliflozin patients (12.8%) experienced hypoglycemia (dangerously low blood glucose) compared to placebo patients (3.7%).
The bottom line
This study concluded that dapagliflozin safely and effectively lowered blood glucose levels in patients with type 2 diabetes uncontrolled by metformin and sulfonylureas.
Published By :
Diabetes Care
Date :
Jan 15, 2015