Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the <scp>DEPICT</scp>‐2 study): 52‐week results from a randomized controlled trial

Mathieu, Chantal; Rudofsky, Gottfried; Phillip, Moshe; Araki, Eiichi; Lind, Marcus; Arya, Niki; Thorén, Fredrik; Scheerer, Markus F.; Iqbal, Nayyar; Dandona, Paresh

doi:10.1111/dom.14060

Cited by 42 publications

(66 citation statements)

References 28 publications

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“…Weight reduction was seen in patients as shown in Table 2. The most significant finding was a decrease of up to 5% as compared to placebo [18]. Weight loss can be attributed to the loss of calories in the urine.…”

Section: Non-glycemic Benefits Of Sglt2 Inhibitorsmentioning

confidence: 94%

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Use of Sodium-Glucose Co-Transporter-2 Inhibitors in Type 1 Diabetics: Are the Benefits Worth the Risks?

Fatima¹,

Sedrakyan²,

Awan³

et al. 2020

Cureus

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The mainstay of treatment for type 1 diabetes is insulin. The use of insulin for tight glycemic control is the key to preventing micro-and macrovascular complications, but it can also lead to hypoglycemic episodes. Therefore, there is a need for the introduction of a drug that can maintain glucose levels within a safe range without increasing the risk of hypoglycemia. For this reason, SGLT2 (sodium-glucose co-transporter-2) inhibitors has been a hot topic in the last couple of years. They have been proved very efficient in treating type 2 diabetes. Many trials on the safety and efficacy of SGLT2 inhibitors have been done on type 1 diabetics. Some other studies have also been done that prove their benefits in increasing arterial efficacy and reducing GFR (glomerular filtration rate). This review article discusses the benefits and risks. The literature search was performed using PubMed, and after applying the inclusion and exclusion criteria, 16 published papers were found. All relevant articles on the topic have been included. Our review has shown that the benefits of SGLT2 inhibitors outweigh their risks. Their benefits include good glycemic control, HBA1c (glycated haemoglobin) reduction, weight loss, and blood pressure improvement. Furthermore, improvement in GFR and arterial efficacy is also significant. Side effects such as UTI (urinary tract infection) and genital infection have been observed, but their incidence is low. However, DKA (diabetic ketoacidosis) and hypoglycemia are severe side effects that should be highlighted. Hypoglycemia can be prevented by strictly monitoring blood sugar levels. The patient must be educated and counseled about DKA and its symptoms. This will ensure the safety of the patient as euglycemic DKA can prove fatal if not diagnosed earlier. So, SGLT2 inhibitors can be used as an effective drug to control blood sugar levels in type 1 diabetes, especially in patients with a BMI higher than 30. It will not only achieve the treatment goals but can also decrease the morbidity and mortality of the patients. However, more studies need to be done to fully understand DKA caused by SGLT2 inhibitors.

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Section: Non-glycemic Benefits Of Sglt2 Inhibitorsmentioning

confidence: 94%

“…Only, two studies mentioned changes in blood pressure. A meta-analysis of sotagliflozin [17] mentioned a 4mm Hg drop, while the DEPICT-II trial observed an average 3mm Hg reduction with 5mg and 7mm Hg with 10mg dapagliflozin [18].…”

Section: Non-glycemic Benefits Of Sglt2 Inhibitorsmentioning

confidence: 99%

Use of Sodium-Glucose Co-Transporter-2 Inhibitors in Type 1 Diabetics: Are the Benefits Worth the Risks?

Fatima¹,

Sedrakyan²,

Awan³

et al. 2020

Cureus

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“…DEPICT-2 was the second of two, randomized, doubleblinded, placebo-controlled, 52-week phase 3, multicenter clinical trials providing further supportive evidence for the use of dapagliflozin as an adjunct therapy in T1D. 70 The study design being similar to DEPICT-1, participants were from different geographical regions, the DEPICT-1 trial having majority subjects of European descent but DEPICT-2 trial having~20% from the Asia-Pacific region. At 52 weeks, dapagliflozin 5 and 10 mg were associated with a significant reduction in HbA1c .…”

Section: Sglt1 and Sglt2 Inhibitorsmentioning

confidence: 99%

“…Additionally, these agents reduce the magnitude of postprandial glucose excursions and increase glucose time-in-range (BG 70-180 mg/dL) as supported by the CGM data. [69][70][71]74 Improved glycemic control is accompanied by a meaningful (3%-5% of bodyweight from baseline) and sustained weight loss with these agents, which is due to fat reduction related to caloric loss from increased glycosuria. The beneficial effect of SGLT1/SGLT2 inhibitors on weight may help to rectify the negative effect of weight gain associated with intensive insulin treatment on cardiovascular risk profile.…”

Section: Sglt1 and Sglt2 Inhibitorsmentioning

confidence: 99%

Adjunct therapies in treatment of type 1 diabetes

Goyal

Sattar

Johnson

et al. 2020

Journal of Diabetes

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In spite of developments with novel insulin preparations, novel modes of insulin delivery with insulin infusion pumps, and the facility of continuous glucose monitoring, only 20% of patients with type 1 diabetes are under adequate control. The need for innovation is clear, and, therefore, the use of adjunct therapies with other pharmacological agents currently in use for type 2 diabetes, has been tried. Currently, pramlintide is the only agent licensed for use in this condition in addition to insulin. Global trials have been conducted with liraglutide, a glucagon‐like peptide 1 receptor agonist (GLP‐1RA), dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and sotagliflozin, an inhibitor of both SGLT1 and SGLT2 transporters. While dapagliflozin and sotagliflozin have now been licensed for clinical use in this condition in Europe and Japan, they have hitherto not been licensed in the United States due to a small increase in the risk of diabetic ketoacidosis. However, these agents reduce glycosylated hemoglobin (HbA1c) by 0.4%, reduce glycemic oscillations, and do not increase the risk of hypoglycemia. Liraglutide, on the other hand, induced a smaller reduction in HbA1c and thus was not considered for a license. However, further trials are currently being conducted with a combination of semaglutide, the most potent GLP‐1RA, and dapagliflozin to determine whether this approach would yield better outcomes.

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“…Combined, 813 patients with inadequately controlled T1DM were studied. [17][18][19][20][21] HbA1c decreased significantly with both doses of dapagliflozin up to 52 weeks (Table 1). There was an improvement in TIR of approximately 10% (9.02% for dapaglilozin 5 mg and 10.70% for dapagliflozin 10 mg), which meant that patient's glucose levels were within the target zone for an extra 2 h a day (p < 0.0001) ( Table 1).…”

Section: Introductionmentioning

confidence: 97%

SGLT inhibitors in type 1 diabetes: weighing efficacy and side effects

Janssens

Caerels

Mathieu

2020

Therapeutic Advances in Endocrinology

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Even before sodium-glucose cotransporter inhibitors (SGLTi) became popular agents for the treatment of people with type 2 diabetes (T2DM), clinicians had explored their potential as adjunct therapies in type 1 diabetes (T1DM). Several trials have demonstrated improved glycemic control (compared with placebo) and a decrease in glucose variability with a clinically relevant increase of time in range. In addition, weight loss and decreased systolic blood pressure are observed. The magnitude of the effects observed depends on the type of SGLTi, the dose administrated, and the duration of observation in the studies. As seen in T2DM, there was an increase in the risk of urogenital mycotic infections, but no increase in the risk of severe hypoglycemia. However, concerns arose regarding an increase in incidence of diabetic ketoacidosis. Mitigation strategies, including careful patient selection, extensive education of patients and (para)medical personnel, adequate insulin dose titration, and the adoption of a ketone-centered approach, are suggested. In different areas of the world, SGLTi are approved for use in T1DM with restrictions concerning patient selection and SGLTi dose. Real-world data on the effect of introduction of SGLTi in people with T1DM will yield insight on the robustness of glycemic effects over time, and allow us to determine whether the positive risk–benefit profile observed in clinical trials can be translated to the real world.

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Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial

Cited by 42 publications

References 28 publications

Use of Sodium-Glucose Co-Transporter-2 Inhibitors in Type 1 Diabetics: Are the Benefits Worth the Risks?

Use of Sodium-Glucose Co-Transporter-2 Inhibitors in Type 1 Diabetics: Are the Benefits Worth the Risks?

Adjunct therapies in treatment of type 1 diabetes

SGLT inhibitors in type 1 diabetes: weighing efficacy and side effects

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