Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial

Matthews, David R.; Paldánius, Päivi M.; Proot, Pieter; Chiang, Yann Tong; Stümvoll, Michael; Prato, Stefano Del

doi:10.1016/s0140-6736(19)32131-2

Cited by 273 publications

(272 citation statements)

References 29 publications

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“…Whereas we previously stated that there was limited evidence for initial combination therapy, the Vildagliptin Efficacy in Combination with Metformin for Early Treatment of Type 2 Diabetes (VERIFY) trial provides additional information. The initial combination of the DPP-4 inhibitor vildagliptin and metformin was shown to provide for a lower rate of secondary failure of glycaemic control to HbA 1c ≥53 mmol/mol (≥7%) vs metformin alone or the sequential addition of metformin and vildagliptin [17]. We now suggest that providers should engage in shared decision making around initial combination therapy in newonset cases of type 2 diabetes.…”

Section: Sglt2 Inhibitor Recommendationsmentioning

confidence: 86%

2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2019

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The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycaemia, based on important research findings from large cardiovascular outcomes trials published in 2019. Important changes include: (1) the decision to treat high-risk individuals with a glucagon-like-peptide 1 (GLP-1) receptor agonist or sodium-glucose cotransporter 2 (SGLT2) inhibitor to reduce major adverse cardiovascular events (MACE), hospitalisation for heart failure (hHF), cardiovascular death or chronic kidney disease (CKD) progression should be considered independently of baseline HbA 1c or individualised HbA 1c target; (2) GLP-1 receptor agonists can also be considered in patients with type 2 diabetes without established cardiovascular disease (CVD) but with the presence of specific indicators of high risk; and (3) SGLT2 inhibitors are recommended in patients with type 2 diabetes and heart failure, particularly those with heart failure with reduced ejection fraction, to reduce hHF, MACE and CVD death, as well as in patients with type 2 diabetes with CKD (eGFR 30 to ≤60 ml min −1 [1.73 m] −2 or urinary albumin-to-creatinine ratio >30 mg/g, particularly >300 mg/g) to prevent the progression of CKD, hHF, MACE and cardiovascular death. Keywords Cardiovascular disease. Chronic kidney disease. Glucose-lowering therapy. Guidelines. Heart failure. Hypoglycaemia. Patient-centred care. Type 2 diabetes mellitus M. J. Davies and J. B. Buse were co-chairs for the Consensus Statement Writing Group. D. D'Alessio and D. J. Wexler were the writing group members for the ADA. C. Mathieu, G. Mingrone, P. Rossing and A. Tsapas were the writing group members for the EASD.

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Section: Sglt2 Inhibitor Recommendationsmentioning

confidence: 86%

2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2019

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“…Whereas we previously stated that there was limited evidence for initial combination therapy, the Vildagliptin Efficacy in Combination with Metformin for Early Treatment of Type 2 Diabetes (VERIFY) trial provides additional information. The initial combination of the DPP-4 inhibitor vildagliptin and metformin was shown to provide for a lower rate of secondary failure of glycemic control to HbA 1c $53 mmol/mol ($7%) versus metformin alone or the sequential addition of metformin and vildagliptin (17). We now suggest that providers should engage in shared decision making around initial combination therapy in new-onset cases of type 2 diabetes.…”

Section: Changes To Consensus Recommendationsmentioning

confidence: 90%

2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2019

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The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycemia, based on important research findings from large cardiovascular outcomes trials published in 2019. Important changes include: 1) the decision to treat high-risk individuals with a glucagon-like peptide 1 (GLP-1) receptor agonist or sodium-glucose cotransporter 2 (SGLT2) inhibitor to reduce major adverse cardiovascular events (MACE), hospitalization for heart failure (hHF), cardiovascular death, or chronic kidney disease (CKD) progression should be considered independently of baseline HbA 1c or individualized HbA 1c target; 2) GLP-1 receptor agonists can also be considered in patients with type 2 diabetes without established cardiovascular disease (CVD) but with the presence of specific indicators of high risk; and 3) SGLT2 inhibitors are recommended in patients with type 2 diabetes and heart failure, particularly those with heart failure with reduced ejection fraction, to reduce hHF, MACE, and CVD death, as well as in patients with type 2 diabetes with CKD (estimated glomerular filtration rate 30 to £60 mL min-1 [1.73 m]-2 or urinary albumin-to-creatinine ratio >30 mg/g, particularly >300 mg/g) to prevent the progression of CKD, hHF, MACE, and cardiovascular death. The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) requested a brief update of the 2018 recommendations on management of hyperglycemia (1,2), based on the important research findings published in 2019, with a particular focus on new data from large cardiovascular outcomes trials (CVOTs). The authors began work on the brief update in July 2019 and submitted it for publication in Diabetes Care and Diabetologia in October 2019. Work was conducted over a series of phone calls and by electronic interactions. This brief update provides a summary of the implications of this new evidence on recommendations for the management of hyperglycemia in type 2 diabetes (see text box), which will be addressed more fully in the ADA Standards of Medical Care in Diabetesd2020 (https://professional.diabetes.org/ SOC). It should be considered in conjunction with the 2018 consensus report (1,2). The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial of the glucagon-like peptide 1 (GLP-1) receptor agonist dulaglutide

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“…16,17 The reasons why we suggest using DPP-4 inhibitors preferentially are its low risk of hypoglycemia, neutral effect on body weight change, rare occurrence of major side effects and recent evidence to improve long-term glycemic durability, consistent with "VERIFY" study with the strategy of an early combination treatment approach with DPP-4 inhibitors plus metformin. 18 However, more consensus is needed to determine what a good response means, such as a great △HbA1c level or an HbA1c achievement <7%, which is a treatment target of the current guidelines. 19,20 It is difficult to answer that reduction of HbA1c from 9% to 8% or from 7.5% to 6.8% is a better response.…”

Section: Discussionmentioning

confidence: 99%

“…Early synergistic combination treatment potentially enhances the clinic efficacy, which is well established from many studies and significantly increases glycemic durability, which is supported by the recent "VERIFY" study. 18 This may be attributed to the complementary mechanism of combination treatment and relatively preserved β-cell function in patients with short duration of T2DM. Long-term T2D duration entails a progressive decline in β-cell function and failure in glycemic control due to the impaired capacity of insulin secretion by insulin secretagogues (sulfonylureas) and DPP4-inhibitors, which was described by Brath et al 32 Moreover, while long duration of T2DM might develop hyperglycemic memory and epigenetic alterations, standard-of-care initial monotherapy following by initial failure and sequential combination might be introspected in the future.…”

Section: Discussionmentioning

confidence: 99%

<p>Predictors of the Efficacy of Dipeptidyl Peptidase-4 Inhibitors in Taiwanese Patients with Type 2 Diabetes Mellitus</p>

Lin

Huang

2019

DMSO

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Background/purpose: Dipeptidyl peptidase-4 (DPP-4) inhibitors are the most popular oral antidiabetic drugs (OADs) in recent 20 years because of the low risk of hypoglycemia, intermediate efficacy to lower glycated hemoglobin (△HbA1c): 0.5-0.9%, neutral effect on body weight change, convenience for usage (mostly once daily), and rare occurrence of major side effects. The purpose of this study was to determine the important predictors of the efficacy of naïve use of DPP-4 inhibitors in Taiwanese patients with type 2 diabetes mellitus (T2D). Methods: A retrospective observational study was conducted. Of the T2D patients, 193 (122 men) naïve DPP-4 inhibitor users with an age of 58.0 ± 12.6 years, disease duration 5.4 ± 4.7 years, body mass index (BMI) 26.1 ± 4.3 kg/m 2 , and estimated glomerular filtration rate 95.9 ± 27.0 mL/min/1.73M 2 were assessed for △HbA1c in 6 months. Results: After 6 months of DPP-4 inhibitors use, mostly second or third line of OADs (2.8 ± 0.7 kinds of OADs), 193 T2D patients (mean baseline HbA1c: 8.4 ± 1.4%) had △HbA1c 1.1 ± 1.2% on average (P < 0.01). The group with a higher baseline HbA1c level had more effective efficacy (△HbA1c ≥0.5%) in lowering HbA1c. Single regression analysis showed that the change in HbA1c after 6 months of treatment was positively associated with the baseline HbA1c level (R = 0.71, P < 0.001). In addition, multiple regression analysis showed that contributors to decrease HbA1c level after 6 months were high baseline HbA1c level, low BMI, short T2D duration, and fewer kinds of OADs. Conclusion: Our study suggested that high baseline HbA1c level, low BMI, short T2D duration, and fewer kinds of OADs are the predictors of the efficacy of DPP-4 inhibitors in Taiwanese patients with T2D. The baseline HbA1c level, in particular, played the most important role in effective efficacy (△HbA1c ≥0.5%).

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Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial

Cited by 273 publications

References 29 publications

2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

<p>Predictors of the Efficacy of Dipeptidyl Peptidase-4 Inhibitors in Taiwanese Patients with Type 2 Diabetes Mellitus</p>

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