The future could hold more treatment options for patients with type 1 diabetes, as research looks at dapagliflozin for type 1.
Type 1 diabetes is an autoimmune disease that destroys the beta cells in the pancreas. About 5% of the population with diabetes are diagnosed with type 1. Although patients with type 2 diabetes have multiple drug classes to choose from for treatment, patients with type 1 diabetes have been limited in treatment options for managing their condition. Insulin is one of the few options that has been available for patients with type 1 diabetes. The European Medicines Agency extended the indication for dapagliflozin for patients with type 1 diabetes based on two trials. Still, these treatments have not been FDA approved for patients with type 1 diabetes. With more clinical trials, patients with type 1 diabetes will one day have more options to choose from.
Two trials were conducted to determine if the risk outweighed the benefit of the SGLT-2 inhibitor dapagliflozin when it was added to the medication regimen for a patient with type 1 diabetes. The trials assessed the impact of glycemic control when adding dapagliflozin 5 mg tablets or a placebo to a patient’s regimen of insulin. Patients with type 1 diabetes had to have a body mass index of ≥ 27 kg/m2, A1C values between 7.5%- 10.5%, and insulin alone was not controlling glycemic levels. Although the European Medicines Agency has approved dapagliflozin for patients with type 1 diabetes, the Food and Drug Administration decided against the approval for type 1 diabetes with the panel having an even split in the decision.
Patients that were taking dapagliflozin had an average decrease in A1C of about 0.4% from baseline after 24 weeks on treatment. Patients that were on dapagliflozin treatment saw an average of 2.6 kg of weight loss and a decrease of about 4mmHg in their systolic blood pressure compared to patients that were taking the placebo. When comparing dapagliflozin to placebo, 4% of the patients taking dapagliflozin reported diabetic ketoacidosis to the 1% on the placebo, with two-thirds of the reports of DKA being moderate to severe. It was reported that 5 of 25 cases of diabetic ketoacidosis were within glycemic control range. Genital infections were reported higher in patients that were on dapagliflozin than patients on placebo, 11.1% vs. 2.3%, respectively. The European Medicine Agency has determined that dapagliflozin is the only treatment option for patients with type 1 diabetes that are overweight. These two studies did not include macrovascular or microvascular outcomes.
The European Medicines Agency extended the indication for patients with type 1 diabetes and body mass index ≥ 27 kg/m2 to take dapagliflozin when insulin as monotherapy did not adequately control glycemic levels. Patients with type 1 diabetes that required insulin dose injection of at least 0.5units /kg of body weight per day were determined to be a cost-effective option by the National Institute of Health and Care Excellence. It is recommended that the patients to be part of an education program for diabetic ketoacidosis to be taught the risks of DKA and learn how to monitor ketones and when to seek for medical help, to be treated by a specialist doctor, to stop the medication if there is no improvement of glycemic control after six months, and to educate patients on the importance of avoiding alcohol and illicit drug use during treatment. The study should have assessed macrovascular or microvascular outcomes for patients taking dapagliflozin. This study can show that there could potentially be additional treatments available for patients with type 1 diabetes. Each patient should be evaluated to determine the risk verse benefits when added to dapagliflozin.
- Patients with type 1 diabetes should only take dapagliflozin if their BMI ≥ 27 kg/m2 and insulin alone is not adequately controlling glycemic levels.
- Patients need to be part of an education program for diabetic ketoacidosis to be taught the risks of DKA and learn how to monitor ketones and when to seek medical help.
- Dapagliflozin should be discontinued after six months if there is not sufficient improvement of glycemic control.
Erskine, David. “Dapagliflozin for Type 1 Diabetes: Ensuring Benefits Outweigh the Risks.” Drug and Therapeutics Bulletin, BMJ Publishing Group Ltd, 1 Mar. 2020, dtb.bmj.com/content/58/3/34.
Karlena Pope, PharmD Candidate, South College School of Pharmacy