BOSTON — A large number of patients who achieved significant weight loss after 1 year of treatment with dapagliflozin as add-on therapy to metformin appeared to maintain that weight loss at 4 years, regardless of whether they were overweight or obese, according to data presented at the American Diabetes Association (ADA) 75th Scientific Sessions.
It is well documented that dapagliflozin improves glycemic control and reduces body weight in patients with type 2 diabetes. Studies have confirmed that body weight loss in overweight and obese patients with type 2 diabetes is associated with improvements in quality of life as well as glycemic control. Other potential cardiovascular (CV) benefits also are associated with body weight loss in overweight and obese patients with type 2 diabetes.
To evaluate whether overweight and obese patients with type 2 diabetes treated with dapagliflozin maintain their weight loss up to 4 years, Eva Johnsson, MD, PhD, an employee of AstraZeneca, and colleagues conducted a post-hoc analysis of a multicenter, double-blind, randomized, controlled phase 3 trial that was part of the dapagliflozin development program.
In the study, dapagliflozin was compared with glipizide, with glycemic efficacy serving as the primary measure. For this post-hoc analysis, the researchers looked at body weight at 1, 2, 3 and 4 years.
Patients were randomly assigned to receive dapagliflozin (n=406) or glipizide (n=408). All patients were on stable doses of metformin, but their diabetes was not sufficiently controlled. They had HbA1c levels ranging from 6.5% to 10% at randomization.
Patients were a little younger than 60 years, and there were slightly more men than women. The majority were white with a duration of diabetes of about 6 years. BMI at baseline was 31 to 32, and HbA1c at baseline was 7.7% in both treatment arms.
Mean body weight loss was 3.55 kg after 1 year in the dapagliflozin arm and maintained up to week 208, whereas in the glipizide arm, weight gain occurred and was maintained for the first 2 years but decreased after 4 years.
The proportion of patients who achieved weight loss was more than 85% in the dapagliflozin group vs. slightly less than 25% in the glipizide group, regardless of baseline BMI, according to the data.
Johnsson also reported that the proportion of patients achieving weight loss of at least 5% of their baseline body weight at 1 year was about 29% in the dapagliflozin group. This gradually decreased up to 4 years, but it remained substantially larger than the comparator, she said.
Safety profiles were similar between the treatment groups, with two exceptions, according to Johnsson. There were three major hypoglycemic events in the glipizide group, while there were more confirmed genital infections in the dapagliflozin group.
“Overall, a larger number of patients on dapagliflozin maintained weight loss up to 4 years with a well tolerated safety profile,” Johnsson said.
- Johnsson E et al. Abstract 103-OR: Maintenance of Weight Loss with Dapagliflozin vs. Glipizide as Add-on to Metformin over 4 Years. Presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.