In a nutshell
This study examined whether empagliflozin (Jardiance) is safe and effective in type 1 diabetics taking insulin.
Some background
Patients with type 1 diabetes (T1D) require daily insulin, a hormone which decreases blood glucose (sugar) levels. A drug called empagliflozin is taken orally and decreases blood glucose levels by increasing the excretion of glucose in the urine. It is currently approved for use in patients with type 2 diabetes and is known to improve control of blood glucose levels, increase weight loss, reduce blood pressure and reduce episodes of low blood glucose levels. However, its safety and effectiveness in T1D patients receiving insulin is currently unknown.
Methods & findings
This study aimed to determine the safety and effectiveness of empagliflozin in insulin-treated T1D patients.
This study involved 75 T1D patients divided into 4 groups. One group received 2.5 mg empagliflozin, another group received 10 mg empagliflozin and a third group received 25 mg empagliflozin. The remaining group received a placebo (substance with no therapeutic effect).
The drug or placebo were taken once daily for 4 weeks. Patients also received daily insulin.
After 4 weeks, HbA1c (average blood glucose over 3 months) was 0.14% lower in participants receiving empagliflozin compared to the placebo group. The daily insulin dose decreased by 0.07-0.09 U/kg in participants receiving empagliflozin compared to placebo. Participants receiving empagliflozin lost between 1.4 and 1.7 kg of weight, in comparison to 0.2 kg in the placebo group.
Adverse events occurred in 94.7% of participants receiving the placebo, 89.5% of participants receiving 2.5 mg empagliflozin, 78.9% of participants receiving 10 mg empagliflozin and 100% of participants receiving 25 mg empagliflozin.
The most common adverse event was hypoglycemia (dangerously low blood glucose levels). However, there was no difference in the frequency of hypoglycemia between the placebo and treatment groups.
The bottom line
This study concluded that empagliflozin, in conjunction with insulin, improves control of blood glucose levels, increases weight loss and reduces insulin dose in T1D patients.
The fine print
The safety and effectiveness of empagliflozin should ideally be assessed over a longer period. The sample size of 75 patients was also quite small.
This study was funded by Boehringer Ingelheim and Eli Lily, the pharmaceutical companies which jointly developed the drug.
Published By :
Diabetes, Obesity and Metabolism
Date :
Jun 17, 2015
