In a nutshell
The aim of the study was to investigate how safe and effective dapagliflozin (Forxiga, Farxiga) is as an add-on therapy to insulin in type 1 diabetes. The main finding of the study was that dapagliflozin led to better blood sugar control and weight loss but increased the risk of complications in these patients.
Some background
The aim of treatment in type 1 diabetes (T1D) is to normalize blood sugar. Currently, this is done by using insulin injections. The side effects of insulin therapy are weight gain and blood sugars dropping too low (hypoglycemia).
Dapagliflozin is a blood sugar lowering drug used in the treatment of type 2 diabetes. It is an SGLT2 inhibitor. It works by blocking the uptake of sugar in the kidney back into the blood. Instead, the sugar gets removed from the body in the urine. The safety and effectiveness of dapagliflozin in T1D are still under investigation.
Methods & findings
This study included 708 insulin-treated patients with T1D. Patients were randomly assigned to receive either 5mg dapagliflozin, 10mg dapagliflozin or a placebo (a drug that has no effect on the body). Blood sugar control was measured through HbA1c (blood test measuring average blood sugar control over 3 months). The study lasted for 52 weeks.
After 52 weeks, patients treated with dapagliflozin had up to 0.31% reduction in their HbA1c levels compared to placebo. The reduction was higher with the 10mg dose.
In addition, patients treated with dapagliflozin experienced up to 3.65kg weight loss. The weight loss was greater in those treated with 10mg dapagliflozin. The dapagliflozin-treated patients needed lower doses of insulin throughout the study.
The patients treated with dapagliflozin had a higher number of undesired harmful effects such as respiratory tract and urinary tract infections. All groups had a similar number of episodes of hypoglycemia. However, patients treated with dapagliflozin had a significantly higher number of diabetic ketoacidosis (DKA) events. DKA a potentially life-threatening complication of diabetes. It happens when the body does not have enough insulin to get energy from glucose. Instead, the body breaks down fat for energy, producing blood acids called ketones. This results in very high blood sugar levels.
The bottom line
The authors concluded that dapagliflozin can improve blood sugar control and weight loss in patients with T1D but increases the risk of DKA.
The fine print
This study was funded by Bristol-Myers Squibb in partnership with AstraZeneca, the developer of dapagliflozin.
Published By :
Diabetes Care
Date :
Oct 23, 2018
