Farziga (dapagliflozin) may be promising as an add-on drug treatment in youth and young adults with type 2 diabetes, according to a new study published in the journal The Lancet Diabetes & Endocrinology.
Farxiga has gained renewed attention in recent years as a treatment option for type 2 diabetes, largely because of benefits it may offer that aren’t directly related to blood glucose control. Based on study results in people with diabetes that appeared to show kidney-related benefits linked to the drug, researchers carried out a trial involving people without diabetes who took the drug for chronic kidney disease — and found that the drug had an overwhelming benefit for kidney disease regardless of diabetes status. Since then, Farxiga has been approved in the United States as a treatment for both a common form of heart failure (inability to adequately pump blood throughout the body) and chronic kidney disease — regardless of diabetes status. In people who don’t have diabetes or elevated blood glucose, the drug appears to have no significant glucose-lowering effect.
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For the latest study, though, researchers were interested mainly in the glucose-lowering effects of Farxiga when added to other treatments for type 2 diabetes. The study participants were 72 people with type 2 diabetes between the ages of 10 and 24. The average age of participants was 16.1 years old, and 19 participants (26%) were at least 18 years old. Even though this study was fairly small in terms of the number of subjects, these participants were recruited from 30 treatment centers in five countries — the United States, Mexico, Hungary, Israel, and Russia. All participants had a starting A1C level (a measure of long-term blood glucose control) between 6.5% and 11%, and they were randomly assigned to either a treatment group or a control group. Members of the treatment group (38 participants) took 10 milligrams of Farxiga daily — in addition to any diabetes treatments they already took — for 24 weeks. During this period, members of the control group (33 participants) took a placebo, or inactive pill. But after the initial 24-week period, both groups took Farxiga daily for 28 weeks to help evaluate the safety of adding Farxiga to existing diabetes treatments in this age group.
Addition of Farxiga linked to reduced A1C levels
The researchers found that after the initial 24 weeks, members of the treatment group had an average A1C level that was 0.25% lower than at the start of the study, while members of the control group had an average A1C level that was 0.50% higher. This difference of 0.75% didn’t quite reach statistical significance — meaning there was a greater than 5% likelihood of the A1C benefit being due to chance. But when researchers looked only at participants who reported following their protocol almost exactly — 34 in the treatment group and 26 in the control group who took their daily pill as assigned — the results looked somewhat different. In this analysis, members of the treatment group had an average A1C reduction of 0.51%, while members of the control group had an average A1c increase of 0.62%, for an average difference of 1.13% that was clearly statistically significant.
The researchers concluded that in younger people with type 2 diabetes who took their treatment as assigned, Farxiga appeared to be a beneficial add-on treatment when it came to blood glucose control. The treatment also didn’t raise any new safety concerns, and there was a low overall risk for severe hypoglycemia (low blood glucose). These results suggest that Farxiga could be a useful additional treatment for younger people with type 2 when other treatments aren’t enough for good blood glucose control.