Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: A randomized controlled trial

Yang, Wenying; Pan, Chang Yu; Tou, Conrad; Zhao, June; Gause‐Nilsson, Ingrid

doi:10.1016/j.diabres.2011.07.035

Cited by 88 publications

(90 citation statements)

References 22 publications

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“…The efficacy and safety of saxagliptin for T2DM treatment have been demonstrated in a large number of clinical trials within the saxagliptin clinical development programme [9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Saxagliptin significantly reduced glycaemic parameters, including haemoglobin A1c (HbA1c), fasting plasma glucose and post-prandial plasma glucose, and allowed more patients to achieve glycaemic targets recommended in treatment guidelines [23,24], compared with placebo [17,18] or control treatments [11-13, 16, 25].…”

Section: Introductionmentioning

confidence: 99%

Bioequivalence of Saxagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets and Single-Component Saxagliptin and Metformin XR Tablets in Healthy Adult Chinese Subjects

Gummesson

Gillen

et al. 2014

Clin Drug Investig

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Section: Introductionmentioning

confidence: 99%

Bioequivalence of Saxagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets and Single-Component Saxagliptin and Metformin XR Tablets in Healthy Adult Chinese Subjects

Gummesson

Gillen

et al. 2014

Clin Drug Investig

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“…In patients with T2DM inadequately controlled on metformin alone (> 1500 mg/day), saxagliptin 5 mg added to metformin provided sustained clinically meaningful glycemic improvements (reductions in HbA1c, fasting -FPG -and postprandial -PPG -plasma glucose levels) after 24 weeks [15,16], which were sustained over 102 weeks [17]. Combination therapy was generally well tolerated with no increase in hypoglycemia or body weight.…”

Section: Introductionmentioning

confidence: 99%

Metformin + saxagliptin for type 2 diabetes

Scheen

2011

Expert Opinion on Pharmacotherapy

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Metformin is considered as the first-line drug therapy for the management of type 2 diabetes.Dipeptidyl peptidase-4 inhibitors, by promoting insulin secretion and reducing glucagon secretion in a glucose-dependent manner, offer new opportunities for oral therapy after failure of metformin. Saxagliptin, a DPP-4 inhibitor, and metformin may be administered together, separately or in fixed-dose combination (FDC) [1,2]. Metformin is considered as the firstline or reference drug because of its favourable overall profile, including its glucose-lowering activity, no weight gain or even slight weight loss, low risk of hypoglycemia and reduction in cardiovascular events [3]. Once metformin fails to maintain glycemic control, there is, however, no consensus about the next pharmacological strategy [1,4] [7] guidelines. Indeed, the addition of a DPP-4 inhibitor to metformin may be a logical option because of the almost similar effect on glycated hemoglobin (HbA1c) compared to the addition of a sulfonylurea or TZD, and because this incretin-based intervention is associated with a excellent tolerance profile, neutral effects on body weight, an absence of hypoglycemic risk and possible positive effects on beta-cell function [3,8].Furthermore, preliminary data suggested that DPP-4 inhibitors may be associated with a reduced rate of cardiovascular events [9], an effect that is currently tested in several prospective clinical trials [6]. Fixed-dose combinations (FDC) combining metformin plus sitagliptin and metformin plus vildagliptin are already commercialized, and a metformin extended-release (XR) plus saxagliptin FDC is already on the market in the US (Kombiglyze®). [10][11][12]. A saxagliptin/metformin immediate release FDC will also be available in Europe very soon (Komboglyze®). Saxagliptin/metformin XR 5? mg/500? mg and saxagliptin/metformin XR 5? mg/1000? mg FDCs were shown to be bioequivalent to individual tablets of saxagliptin and metformin of the same strengths [13]. Of note, however,

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“…Four abstracts that had been included in the previous analysis were replaced by full-text publications. In total,19 studies were included in the base case analysis at 24-weeks ± 6 weeks [7,23,[25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41] (Table S2) and a further 4 were eligible for the sensitivity analysis due to timeframe (± 8 weeks) and quality issues (Table S4). Of the 15 studies reporting data at the 52-week time point, 8 were included in the base case analysis [8,[42][43][44][45][46][47][48] (Table S3) with the remaining 7 assessed in the sensitivity analysis for the same reasons (timeframe and quality issues) (Table S4).…”

Section: Systematic Review Search Resultsmentioning

confidence: 99%

Systematic Review and Network Meta-analysis to Compare Dapagliflozin with other Diabetes Medications in Combination with Metformin for Adults with Type 2 Diabetes

Barnett

Me²,

Fenici³

et al. 2014

Intern Med

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Objective: A network meta-analysis (NMA) update was undertaken to evaluate the sodium glucose cotransporter-2 (SGLT-2) inhibitor, dapagliflozin, versus other antidiabetes medications as add-on to metformin. This update allowed inclusion of a new drug class (glucagon-like peptide-1 [GLP-1] analogues), a new time point (24-weeks) and covariate analysis. Methods:The systematic review identified randomised controlled trials involving patients with type-2 diabetes mellitus (T2DM) inadequately controlled on metformin. Comparators included dipeptidyl peptidase-4 inhibitors (DPP-4i), thiazolidinediones (TZDs), GLP-1s, sulfonylureas (SUs) and dapagliflozin. Bayesian NMA was conducted at 24-and 52-weeks for mean change in HbA1c, systolic blood pressure (SBP), weight, and proportion of patients experiencing hypoglycaemia. Results:The systematic review identified 2247 articles, of which 16were eligible for inclusion. Combined with 19 studies frompre-2011 analysis, a total of 19 and 8 studies were included in the 24-week and 52-week NMA, respectively. There were no significant differences in HbA1c or SBP between dapagliflozin and other classes, including GLP-1s, at either time point. Significant results were seen for weight loss by 24-weeks for dapagliflozin versusDPP-4i (-2.24 kg [95% CI -3.25,-1.24]) and TZDs (-4.65 kg [-5.89,-3.45]), and at 52-weeks versus SUs, DPP-4i and TZDs. Dapagliflozin also resulted in significantly lower hypoglycaemia risk versus SU (OR: 0.05 [0.01,0.19]) over 52-weeks. Conclusions:This NMA update supports previous findings that effects on HbA1c are similar between drug classes and that dapagliflozin plus metformin offers superior weight control for T2DM patients compared with many other agents. The wider evidence base compared to previous analysis increases the confidence in the results.

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Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: A randomized controlled trial

Cited by 88 publications

References 22 publications

Bioequivalence of Saxagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets and Single-Component Saxagliptin and Metformin XR Tablets in Healthy Adult Chinese Subjects

Bioequivalence of Saxagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets and Single-Component Saxagliptin and Metformin XR Tablets in Healthy Adult Chinese Subjects

Metformin + saxagliptin for type 2 diabetes

Systematic Review and Network Meta-analysis to Compare Dapagliflozin with other Diabetes Medications in Combination with Metformin for Adults with Type 2 Diabetes

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