Global Study Finds Dapagliflozin Benefits Type 1 Diabetic Patients
October 12, 2017
A global study led by Paresh
Dandona, MD, PhD, found a majority of patients with Type 1
diabetes who were treated with dapagliflozin, a Type 2 diabetes
medicine, showed a significant decline in their blood sugar
of the study were published in The Lancet Diabetes &
Endocrinology and presented by Dandona, SUNY Distinguished
Professor of medicine and
chief of endocrinology, diabetes
and metabolism, at the annual meeting of the European
Association for the Study of Diabetes in Lisbon, Portugal.
Multicenter Study Conducted in 17 Countries
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, randomized, three-arm, phase 3 multicenter
study was conducted at 143 sites in 17 countries, including the
Participants were 833 patients ages 18 to 75 who had
inadequately controlled blood sugars with a mean baseline
hemoglobin A1C (HbA1c) level of 8.53. A1C levels under seven for
Type 1 diabetics are considered optimal.
Adjunct Therapy in Addition to Insulin
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,” Dandona says.
“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 adds.
Results Could Lead to Licensing as Anti-Diabetic Agent
In the study, approximately half of the patients taking
dapagliflozin reduced their A1C levels by more than 0.5 percent
without experiencing severe drops in blood sugar
Dandona explains that any fall in HbA1c of around .5 percent is
considered significant and can lead to licensing of a drug as an
anti-diabetic agent. He notes, 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,” says Dandona, who sees
patients through UBMD
Internal Medicine at the Diabetes-Endocrinology
Center of Western New York, which is where the five Buffalo
patients in the study were treated.
Pioneering Research into New Ways of Treatment
Dandona is renowned for his diabetes and metabolic research,
particularly into new treatments that can be used in addition to
insulin, to help patients with Type 1 diabetes achieve better blood
He has led the field globally since he published
an observational study in 2011 that found that another drug for
Type 2 diabetes, liraglutide, could help treat Type 1 diabetes.
“Our key paper in 2011 has led to other drugs being
considered for use in Type 1 diabetes,” he says. “We
have been pioneers in conceptualizing new ways to help Type 1
diabetes patients achieve better outcomes with new
Dandona points out that until these recent developments, there
hadn’t been another significant treatment developed for Type
1 diabetes since the discovery of insulin in 1921.
No Findings of Ketoacidosis
Even Type 1 patients with good glycemic control experience what
Dandona calls “glycemic excursions,” pronounced swings
from hyperglycemic to hypoglycemic, motivating him and his
colleagues to conduct groundbreaking research aimed at discovering
non-insulin drugs that can help improve blood sugar control.
In addition, there was no ketoacidosis — an interesting
aspect of the current study that is contrary to Dandona’s
earlier pilot study with liraglutide and dapagliflozin, in which
there were two cases of ketoacidosis in whom the dose of insulin
had been reduced by 35 percent from the original baseline.
“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 explains, noting that since
these issues were avoided in the DEPICT-1 study, no increase in
ketoacidosis was observed.
International Co-Authors Contribute to Research
Co-authors on the study are researchers from the following
- University of Leuven, Belgium
- Schneider Children’s Medical Center of Israel and Sackler
Faculty of Medicine, Tel Aviv University, Israel
- Juvenile Diabetes Research Foundation, New York City
- Ruhr University Bochum, Germany
Co-authors also included researchers from AstraZeneca and
Bristol-Myers Squibb, the companies that funded the study and
partnered to develop dapagliflozin.