ชนิด 2 ยาโรคเบาหวานพบว่านอกจากนี้ ชนิดของสวัสดิการ 1 เบาหวานอย่างมีนัยสำคัญ

Global study of more than 800 patients led by a University at Buffalo endocrinologist has found that a drug for type 2 diabetes provides significant benefits to type 1 ผู้ป่วยเบาหวาน.

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.

The results are being presented today by the University at Buffalo researcher who led the study at the annual meeting of the European Association for the Study of Diabetes in Lisbon.

Called DEPICT-1, which stands for Dapagliflozin in Patients with Inadequately Controlled Type 1 โรคเบาหวาน, the 24-week study was the first global multicenter investigation of dapagliflozin to test its efficacy and safety in Type 1 โรคเบาหวาน.

-ตาบ, แบบสุ่ม, three-arm, ขั้นตอนการ 3 multicenter study was conducted at 143 เว็บไซต์ใน 17 ประเทศ, รวมถึงสหรัฐอเมริกา. It was funded by AstraZeneca and Bristol-Myers Squibb, the companies that partnered to develop dapagliflozin.

มีผู้เข้าร่วม 833 ผู้ป่วยที่มีอายุ 18-75 who had inadequately controlled blood sugars with a mean baseline hemoglobin A1C (HbA1c) — a measure of sugar in the blood — ระดับของ 8.53. A1C levels for Type 1 diabetics are considered optimal when they are under seven.

Adjunct 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,” said senior author Paresh Dandona, MD, ปริญญาเอก, 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,” เขากล่าวว่า.

ในการศึกษา, approximately half of the patients taking dapagliflozin reduced their A1C levels by more than 0.5 percent without experiencing severe drops in blood sugar (ภาวะน้ำตาลในเลือด). Dandona explained that any fall in HbA1c of around .5 percent is considered significant and can lead to licensing of a drug as an antidiabetic agent. He noted, อย่างไรก็ตาม, that the findings will need further confirmation before the drug can be licensed by the FDA for use in Type 1 โรคเบาหวาน.

Better control in Type 1 โรคเบาหวาน

“Treating the millions of patients living with Type 1 diabetes while also managing the complications associated with the disease remains a daunting challenge,” Dandona กล่าวว่า, who sees patients through UBMD Internal Medicine at the Diabetes and Endocrinology Center of Western New York, which is where the five Buffalo patients in the study were treated.

He 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 sugar control. He has led the field globally since his published work on liraglutide patients with Type 1 โรคเบาหวานใน 2011.

ใน 2011, Dandona published an observational study that found that another drug for Type 2 โรคเบาหวาน, liraglutide, could help treat Type 1 โรคเบาหวาน.

“Our key paper in 2011 has led to other drugs being considered for use in Type 1 โรคเบาหวาน,” เขากล่าวว่า. “We have been pioneers in conceptualizing new ways to help Type 1 diabetes patients achieve better outcomes with new therapies.”

Dandona pointed out that until these recent developments, there hadn’t been another significant treatment developed for Type 1 diabetes since the discovery of insulin in the 1920s.

Even Type 1 patients with good glycemic control experience what he 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.

No ketoacidosis

An interesting aspect of the current study is that contrary to Dandona’s earlier pilot study with dapagliflozin, there was no finding of ketoacidosis, อาการแทรกซ้อนอันตรายที่เกิดขึ้นเมื่อกรดและสารที่เรียกว่าคีโตนสร้างขึ้นในเลือดเนื่องจากการขาดอินซูลิน. “We found out that any reduction of insulin dose greater than 20 ร้อยละ, or the absence of a meal and missing the insulin dose, or the significant intake of alcohol makes you more vulnerable to ketoacidosis,” เขาอธิบายว่า, noting that since these issues were avoided in the DEPICT-1 study, no increase in ketoacidosis was observed.

Dandona and his co-authors are awaiting the final results of the DEPICT-1 patients at 56 สัปดาห์ที่ผ่านมา. “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 โรคเบาหวาน,” เขากล่าวว่า.

Co-authors with Dandona are Chantal Mathieu, มหาวิทยาลัยลูเวน; Moshe Phillip, Schneider Children’s Medical Center of Israel and Sackler Faculty of Medicine; Lars Hansen, บริสตอลไมเยอร์ Squibb; Steven C. Griffen, มูลนิธิวิจัยเบาหวาน; Dietheld Tschope, Ruhr University Bochum and Fredrik Thoren, John Xu and Anna Maria Langkilde, AstraZeneca.

แหล่งที่มา: มหาวิทยาลัยที่บัฟฟาโล
สมุดรายวัน: มีดหมอโรคเบาหวานและต่อมไร้ท่อ
ฟันเดอร์: AstraZeneca, บริสตอลไมเยอร์ Squibb
ห้องประชุม: สมาคมยุโรปสำหรับการศึกษาของโรคเบาหวาน (EASD) การประชุมประจำปี

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