The type 2 diabetes drug dapagliflozin can improve blood glucose levels in people living with type 1 diabetes, according to results from a late-stage clinical trial.
People taking dapagliflozin on the 24-week trial experienced a decrease in HbA1c and greater time in range, compared with those on a placebo.
These successes in glucose management came at a cost though, with more cases of diabetic ketoacidosis (DKA) in those taking the drug.
If approved for clinical use, dapagliflozin would become the first ever additional drug that people living with type 1 diabetes could use alongside insulin to manage blood glucose levels.
Why did they do this trial?
The only treatment at the moment for type 1 diabetes is insulin, which has to be injected or infused through a pump. The manmade insulins we have however are not perfect, and it can be very tricky to balance insulin with a number of other factors, such as food, exercise and illness, to maintain blood glucose levels in the healthy range.
The drug dapagliflozin works to stop the kidneys from absorbing glucose into the body, so some glucose passes out in the urine instead. This helps to reduce blood glucose levels, and dapagliflozin is currently approved for use in type 2 diabetes.
In recent years, the drug has been tested in increasingly advanced trials to see if it can also help people living with type 1 diabetes to manage their blood glucose levels. This work has been funded by pharmaceutical giant AstraZeneca.
What did they find?
813 people with type 1 diabetes and an HbA1c of at least 7.5% across 13 countries took part in the 24-week trial. 271 participants took a small dose of the drug daily, while 270 took a larger dose. A further 272 took a placebo, as a comparison.
Participants taking dapagliflozin had their HbA1c drop on average by 0.37% when on the smaller dose, and by 0.42% when on the larger dose, without an increase in hypos. They also lost weight throughout the study.
Side effects of the drug however included a greater rate of genital infections and more cases of DKA – participants on the placebo did not experience DKA, whereas 13 participants in the drug groups did.
What does this mean for type 1?
The results indicate that dapagliflozin might be a useful additional therapy for those who find managing blood glucose levels challenging.
The increase in DKA however may mean it is not a suitable treatment for all, which the researchers highlighted in their paper:
“..if approved for [clinical use], the DKA risk should be carefully considered if using dapagliflozin for the treatment of type 1 diabetes in the real world.”
What’s the next step?
The team are extending the trial so that it runs for a further 28 weeks. This will let them check how safe and effective dapagliflozin can be over longer periods of time.