Study Shows SGLT2 Inhibitors Can Effectively Control Blood Sugar in Elderly Diabetic Patients Without Reducing Muscle Mass
Results from a recent phase 3 clinical trial conducted by a joint research team, including Gifu University in Japan, have shed light on the effectiveness and safety of using SGLT2 inhibitors to control blood sugar levels in elderly individuals with type 2 diabetes. The study, published in the prestigious journal Diabetes, Obesity and Metabolism, provides evidence that these medications can effectively manage blood sugar without compromising muscle mass or strength.
The primary objective of the study was to evaluate the blood sugar-lowering effects, muscle mass, physical performance, and safety of the SGLT2 inhibitor empagliflozin. The researchers focused on the change in glycated hemoglobin (HbA1c) levels after 52 weeks of treatment compared to the start of the trial. They also examined secondary measures, including changes in muscle mass, body fat mass, lean body mass, total body water, and bone mineral content.
The study included approximately 128 Japanese diabetic patients aged 65 years or older, with an average age of 74.1 years. These individuals had an obesity index (BMI) exceeding 22kg/m² and glycated hemoglobin levels ranging from 7.0% to 10.0%.
- The participants were divided into two groups: one receiving empagliflozin and the other receiving a placebo.
- By comparing glycated hemoglobin levels, the study found that the empagliflozin administration group experienced a 0.57% greater reduction than the placebo group. This effect was consistent across different age groups, sexes, eGFR (glomerular filtration rate), and BMI. (95% confidence interval -0.78, -0.36; p <.0001).
- Furthermore, a higher percentage of individuals in the empagliflozin group achieved the target HbA1c levels (54.7% compared to 22.2%).
Importantly, the study also demonstrated that blood sugar and weight were effectively controlled without any detrimental impact on muscle mass. After 52 weeks, the empagliflozin group exhibited a significant reduction in body weight (-3.27 kg vs. 0.90 kg) compared to the placebo group. However, there was no significant difference observed between the two groups in terms of muscle mass and fat-free mass (body weight excluding fat mass).
An additional encouraging finding from this study was the absence of significant adverse reactions, such as diabetic ketoacidosis, confirmed hypoglycemia, or muscle weakness.
These promising results provide valuable insights into the use of SGLT2 inhibitors as an effective treatment option for elderly individuals with type 2 diabetes. Not only do these medications effectively lower blood sugar levels, but they also maintain muscle mass and overall physical performance. This research contributes to the growing body of evidence supporting the benefits of SGLT2 inhibitors in the management of diabetes in older populations.
Although concerns have been raised about the use of SGLT2 inhibitors in elderly type 2 diabetic patients, research results have shown that blood sugar can be controlled without reducing muscle mass or strength.
A joint research team including Gifu University in Japan published the results of the EMPA-ELDERLY phase 3 clinical trial, which evaluated the effectiveness and safety of blood sugar control in elderly people in their country, in the international journal Diabetes, Obesity and Metabolism.
The primary evaluation index of this study, which evaluated the blood sugar-lowering effect, muscle mass, physical performance, and safety of the SGLT2 inhibitor empagliflozin, was the change in glycated hemoglobin (HbA1c) at week 52 compared to the start of the trial , and the secondary evaluation index was muscle mass and body fat mass at week 52. , changes in lean body mass, total body water, and bone mineral content.
The subjects of the study were approximately 128 Japanese diabetic patients aged 65 years or older (average age 74.1 years). Their obesity index (BMI) is over 22kg/㎡, and glycated hemoglobin (HbA1c) is 7.0-10.0%.
They were divided into an empagliflozin administration group and a placebo group, and the glycated hemoglobin was compared with the placebo. As a result, it was 0.57% lower in the empagliflozin administration group. This was consistent regardless of age, sex, eGFR (glomerular filtration rate), and BMI (95% confidence interval -0.78, -0.36; p <.0001). The rate of reaching the HbA1c target was also higher in the empagliflozin group (54.7% compared to 22.2%).
In addition, blood sugar and weight have been shown to be controlled without reducing muscle mass. At 52 weeks, body weight change was significantly reduced in the empagliflozin group (-3.27 kg vs. 0.90 kg), but there was no significant difference in muscle mass and fat-free mass (body weight excluding fat mass) between the two groups.
In addition, no significant adverse reactions such as diabetic ketoacidosis, confirmed hypoglycemia, or muscle weakness were observed.
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