- Type 1 diabetics who were treated with dapagliflozin observed a decline in blood sugar levels.
- There was no finding of ketoacidosis, a dangerous complication that occurs when acids and substances called ketones build up in the blood due to lack of insulin.
- Dapagliflozin is usually prescribed for type 2 diabetics.
Patients with Type 1 diabetes who were treated with dapagliflozin had a significant decline in their blood sugar levels. Dapagliflozin, a medicine prescribed for Type 2 diabetes and was tested for type 1 diabetics.
The drug is a sodium glucose cotransporter-2 inhibitor (SGLT-2) which was given as an adjunct therapy in addition to the insulin that patients with Type 1 diabetes need to survive.
‘Dapagliflozin is safe and effective in patients with Type 1 diabetes and is a promising adjunct treatment to insulin.’
In 2011, Dandona published an observational study that found that another drug for Type 2 diabetes, liraglutide, could help treat Type 1 diabetes but there was a risk of increase in ketone levels in the blood.
"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 Dr.Paresh Dandona, University at Buffalo.
Dapagliflozin For Type 1 Diabetics
The study, called, Dapagliflozin in Patients with Inadequately Controlled Type 1 diabetes (DEPICT-1) is the first global multicenter investigation of dapagliflozin to test its efficacy and safety in Type 1 diabetes.
It was a multicenter study conducted at 143 sites in 17 countries. The double-blind, randomized, three-arm, phase 3 was funded by AstraZeneca and Bristol-Myers Squibb, the companies that partnered to develop dapagliflozin.
For the study, 833 patients aged 18-75 who had inadequately controlled blood sugars with a mean baseline hemoglobin A1C (HbA1c) of 8.53 were recruited. HbA1c is a measure of sugar in the blood. For Type 1 diabetics, HbA1clevels under 7 is considered normal.
Dr.Paresh Dandona said, "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.
Approximately half of the patients taking dapagliflozin reduced their A1C levels by more than 0.5 percent without experiencing severe hypoglycemia. Dandona explained that any fall in HbA1c of around 0.5 percent is considered significant and can lead to licensing of a drug as an antidiabetic agent
. However, that the findings will need further confirmation before the drug can be licensed by the FDA for use in Type 1 diabetes.
There was no finding of ketoacidosis, a dangerous complication that occurs when acids and substances called ketones build up in the blood due to lack of insulin.
"We found out that any reduction of insulin dose greater than 20 percent, or the absence of a meal and missing the insulin dose, or the significant intake of alcohol makes you more vulnerable to ketoacidosis," he explained.
"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.
The final results of the study will be released after 56 weeks. "If the outcomes are sustained or better at that time, and if a parallel study, DEPICT-2, confirms this, there will likely be an application to the FDA for licensing the drug for use in Type 1 diabetes," he said.
- Paresh Dandona et al., Drug for type 2 diabetes provides significant benefits to type 1 diabetic patients, Lancet Diabetes and Endocrinology (2017).