MedicalResearch.com Interview with:
Chantal Mathieu, MD, PhD
Professor of Medicine
Clinical and Experimental Endocrinology
Catholic University of Leuven, Belgium
MedicalResearch.com: What is the background for this study?
Response: People with type 1 diabetes (T1D) are confronted often with the inability to achieve satisfactory glycemic control, being good HbA1c, but in particular stable glycemic control, avoiding hyperglycemic events, but also hypoglycemic events, despite novel insulins and novel technologies. Moreover, intensive insulin therapy is often associated with weight gain, leading to an increase in overweight and obesity also in people with T1D. All of these issues affect quality of life.
In the DEPICT 2 study we examined the impact of adding a selective SGLT2 inhibitor, dapagliflozin (two doses tested – 5 and 10mg) in a double blinded manner versus placebo to background insulin (MDI or CSII) in people with T1D reaching insufficient glycemic control (HbA1c 7.5-10.5%). Primary endpoint was lowering in HbA1c at 24 weeks and secondary endpoints included insulin dose reduction and weight reduction as well as a composite endpoint of having a HbA1c drop of >=0.5% without severe hypoglycemia. The study ran internationally, with about 1/3 of patients coming from North America, 1/3 from Europe and 1/5 from Asia (Japan).
MedicalResearch.com: What are the main findings?
Response: At 24 weeks, HbA1c dropped by 0.37% and 0.42% versus placebo in the dapagliflozin 5mg and 10mg arms respectively (p<0.0001), with 10.78 and 11.08% less insulin and 3.21% and 3.74% less weight versus placebo for dapagliflozin 5mg and 10mg respectively; The composite endpoint of HbA1c drop >=0.5% without severe hypoglycemia was reached by 39.5% and 41.6% of patients treated with dapagliflozin 5mg and 10mg respectively, versus 20.1% in placebo-treated patients. All these endpoints being highly statistically significant. CGM analysis at 24 weeks showed an approximately 10% greater time in range (>70-180mg/dl) and smaller MAGE (approximately -10mg/dl).
Side effects of therapy included the well-known increased risk of genital infections, but no increase in hypoglycemia (overall or severe) was observed. There was an imbalance in the occurrence of diabetic ketoacidosis (DKA) (all adjudicated. Events were few, but both dapagliflozin doses were associated with more DKA events: 7/271 patients in the dapalgiflozin 5mg arm and 6/270 patients in the dapagliflozin 10mg arm presented with DKA, compared to none in the placebo arm of the study.
MedicalResearch.com: What should readers take away from your report?
Response: The adjunct therapy of the selective SGLT2 inhibitor, dapagliflozin, added to intensive insulin therapy in people with T1D not reaching good glycemic control, improved glycemic control, with lower insulin doses and with lowering of weight. There was a small increase in DKA.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Longer term studies as well as careful analysis of the DKA cases in this study will help us understand the potential of this adjunct therapy. The present data are extremely promising as they show the answer to an unmet need in people with T1D.
Disclosure: This study was sponsored by Astra Zeneca
Efficacy and Safety of Dapagliflozin in Patients with Inadequately Controlled Type 1 Diabetes—DEPICT-2 Study
CHANTAL MATHIEU, PARESH DANDONA, PIETER GILLARD,
PETER A. SENIOR, CHRISTOPH HASSLACHER, EIICHI ARAKI,
MARCUS LIND, STEPHEN C. BAIN, SERGE JABBOUR,
NIKI ARYA, FREDRIK A. THOREN, ANNA MARIA LANGKILDE,
ON BEHALF OF THE DEPICT-2 INVESTIGATORS
ADA 2018 abstract and
Diabetes 2018 May; 67(Supplement 1): -.https://doi.org/10.2337/db18-213-OR
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.