Dapagliflozin Reduces Body Fat in Diabetes Patients

A new study confirms dapagliflozin helps patients with type 2 diabetes lose a few pounds in addition to improving their blood sugar levels.…

What’s noteworthy about the study, say the researchers, is that dapagliflozin leads to loss of fat mass, with significant reductions in both abdominal visceral adipose tissue and subcutaneous adipose tissue.

Dapagliflozin, a highly selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), belongs to a new class of anti-diabetes drugs designed to allow more sugar to be excreted with urine.

In clinical trials, the drug has been shown to improve glycemic control in patients with type 2 diabetes when used alone, or when added to metformin, glimepiride, or insulin. Moderate weight loss has been a consistent finding in these trials, but the exact make up of that weight loss has been unknown.

The objective of the current study was to confirm weight loss with dapagliflozin and establish through body composition measurements whether weight loss is accounted for by changes in fat or fluid.

Dr. Jan Bolinder from the Karolinska Institute in Stockholm and colleagues had 182 overweight middle-aged patients with type 2 diabetes inadequately controlled by metformin add dapagliflozin 10 mg daily or placebo for 24 weeks. As is common with diabetes trials, all patients received general diet and exercise advice.

In a report, Dr. Bolinder and colleagues report that the addition of dapagliflozin improved glycemic control (as expected) and yielded a placebo-corrected reduction in total body weight of 2.1 kg at 24 weeks (p<0.0001).

Compared with placebo, dapagliflozin treatment showed statistically-significant reductions in waist circumference (-1.52 cm; p=0.0143) and fat mass (-1.48 kg; p=0.0001) and in the proportion of patients achieving weight loss of at least 5% (+26.2%; p<0.0001). About two-thirds of the weight loss observed with dapagliflozin was attributable to reductions in fat mass as measured by dual-energy x-ray absorptiometry (fat mass dropped 2.2 kg, whereas lean mass dropped 1.1 kg).

In terms of safety, the proportions of patients with at least one adverse event were similar in the dapagliflozin (43%) and the placebo arm (40%). More patients taking dapagliflozin experienced a serious adverse event (6.6% vs. 1.1%), or were taken off study medication due to a serious adverse event (4.4% vs. 0%).

Earlier this year, U.S. drug regulators said they needed additional clinical data, possibly including new clinical studies, before approving dapagliflozin from AstraZeneca Plc and Bristol-Myers Squibb Co, which sponsored the current study.