Loading ...

TOPLINE:

Combining dapagliflozin with calorie restriction achieved a greater type 2 diabetes (T2D) remission rate and significant changes in body fat and metabolic risk factors than calorie restriction alone.

METHODOLOGY:

• Researchers conducted a multicenter, double blind, randomized, placebo-controlled trial at 16 centers in mainland China from June 2020 through January 2023.
• A total of 328 patients with T2D for less than 6 years were randomly assigned to either calorie restriction alone or calorie restriction with 10 mg dapagliflozin daily for 12 months; the mean age was 46.7 years, 66% were men, the mean body mass index (BMI) was 28.2, the mean A1c was 7.3%, and 45% were treated with metformin at baseline.
• The calorie-restricted diet had an energy deficit of 500~750 kcal per day, with fat < 35% and protein > 15%, based on an individual’s actual daily calorie intake at baseline; all participants received dietary counseling, kept a food log, and were encouraged to be physically active (150 minutes of brisk walking every week or > 10,000 steps per day).
• The primary outcome was diabetes remission, defined as glycated hemoglobin < 6.5% and fasting plasma glucose < 126 mg/dL in the absence of all antidiabetic drugs for at least 2 months.

TAKEAWAY:

• At 12 months, 44% of participants in the calorie restriction plus dapagliflozin group were in remission compared with 28% in the calorie-restriction-only group (risk ratio, 1.56).
• At 12 months, there also was a significantly greater reduction in body weight (difference, 1.3 kg) and homeostatic model assessment for insulin resistance (difference, −0.8) in the dapagliflozin group.
• Metabolic risk factors were also significantly improved in the dapagliflozin group, including body fat mass, systolic blood pressure, fasting plasma glucose, A1c, high density lipoprotein cholesterol, and triglycerides.
• No significant between-group differences in adverse events were detected.

IN PRACTICE:

“Our results support the strategy of dapagliflozin plus regular calorie restriction...as an effective and sustainable approach for remission of diabetes in patients with early type 2 diabetes,” the authors wrote.

In a related editorial, David Hope, MD, and Jonathan Valabhji, MD, of Imperial College, United Kingdom, noted, “The optimal balance of lifestyle components needs to be considered; achieving remission through less intense calorie restriction may prove more inclusive at the population level and may also serve to reduce interventional unit cost.”

SOURCE:

The study was led by Xiaoying Li, MD, of Fudan University, Shanghai, China, and published online in The BMJ.

LIMITATIONS:

The findings cannot be generalized to patients with T2D for more than 6 years or to other races or ethnic groups. Body composition measurement by dual energy x-ray absorptiometry was not done in all centers, and total energy expenditure was not assessed.

DISCLOSURES:

The study was funded by grants from the National Nature Science Foundation of China and National Nature Science Foundation of China for Distinguished Young Scholars, and partially by a grant from AstraZeneca. The authors declared no financial relationships with any organizations that might have had an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.

Hope and Valabhji had no disqualifying financial ties to commercial companies.