A majority of patients with type 1 diabetes who were treated with dapagliflozin, a type 2 diabetes medicine, had a significant decline in their blood sugar levels, according to a new study published in the Lancet Diabetes and Endocrinology.
Called DEPICT-1, which stands for Dapagliflozin in Patients with Inadequately Controlled Type 1 diabetes, the 24-week study was the first global multicenter investigation of dapagliflozin to test its efficacy and safety in type 1 diabetes.
The double-blind, randomised, three-arm, phase three multicentre study was conducted at 143 sites in 17 countries. It was funded by AstraZeneca and Bristol-Myers Squibb, the companies that partnered to develop dapagliflozin.
Participants were 833 patients aged 18 to 75 who had inadequately controlled blood sugars with a mean baseline hemoglobin A1C (HbA1c) – a measure of sugar in the blood – level of 8.53. A1C levels for type 1 diabetics are considered optimal when they are under seven.
The results demonstrate that when this drug, a sodium glucose cotransporter-2 inhibitor (SGLT-2) was administered as an adjunct therapy in addition to the insulin that patients with type 1 diabetes need to survive, it significantly improved outcomes.
‘Our paper provides the initial signal that dapagliflozin is safe and effective in patients with type 1 diabetes and is a promising adjunct treatment to insulin to improve glycemic control,’ said senior author Paresh Dandona, MD, PhD, SUNY Distinguished Professor and Chief of
Endocrinology, diabetes and metabolism in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.
‘The 24-week results from DEPICT-1 are important as they represent the first Phase 3 trial in type 1 diabetes of the newer, selective SGLT-2 class of diabetes medicines as an oral adjunct to insulin,’ he said.
In the study, approximately half of the patients taking dapagliflozin reduced their A1C levels by more than 0.5 per cent without experiencing severe drops in blood sugar (hypoglycemia).
Dandona explained that any fall in HbA1c of around five per cent is considered significant and can lead to licensing of a drug as an antidiabetic agent. He noted, however, that the findings will need further confirmation before the drug can be licensed by the FDA for use in type 1 diabetes.
‘Treating the millions of patients living with type 1 diabetes while also managing the complications associated with the disease remains a daunting challenge,’ said Dandona, who sees patients through UBMD Internal Medicine at the Diabetes and Endocrinology Centre of Western New York, which is where the five Buffalo patients in the study were treated.