Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes

被引:22
作者
Rosenstock, Julio [1 ]
Perl, Shira [2 ]
Johnsson, Eva [3 ]
Garcia-Sanchez, Ricardo [2 ]
Jacob, Stephan [4 ]
机构
[1] Dallas Diabet Res Ctr Med City, 7777 Forest Lane C-685, Dallas, TX 75230 USA
[2] AstraZeneca, Gaithersburg, MD USA
[3] AstraZeneca Gothenburg, Molndal, Sweden
[4] Cardiometab Inst, Villingen Schwenningen, Germany
关键词
dapagliflozin; metformin; phase III study; randomized trial; SGLT2; inhibitor; type; 2; diabetes; INITIAL COMBINATION THERAPY; RANDOMIZED CLINICAL-TRIALS; ADD-ON THERAPY; EFFICACY; SAFETY; EMPAGLIFLOZIN; ASSOCIATION; MELLITUS; SGLT2; MONOTHERAPY;
D O I
10.1111/dom.13795
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aim To evaluate the efficacy and safety of triple therapy with low-dose dapagliflozin plus saxagliptin added to metformin in uncontrolled type 2 diabetes. Materials and methods This 24-week, double-blind trial (NCT02681094) randomized 883 patients (glycated haemoglobin [HbA1c] 7.5-10.0%) on metformin >= 1500 mg/d to add-on dapagliflozin 5 mg/d plus saxagliptin 5 mg/d or to add-on of either monocomponent. The primary endpoint was change in HbA1c from baseline. Results Baseline mean +/- SD patient characteristics were: age 56.7 +/- 10.5 years; HbA1c 8.2 +/- 0.9%; and diabetes duration 7.6 +/- 6.1 years. Triple therapy significantly decreased HbA1c versus dual therapy (-1.03% vs. -0.63% [dapagliflozin] vs. -0.69% [saxagliptin]; P < .0001). More patients achieved HbA1c <7.0% with triple versus dual therapy (41.6% vs. 21.8% [dapagliflozin; P < .0001] vs. 29.8% [saxagliptin; P = .0018]). Triple therapy significantly decreased fasting plasma glucose (-1.5 mmol/L vs. -1.1 mmol/L [dapagliflozin; P = .0135] vs. -0.7 mmol/L [saxagliptin; P < .0001]) and body weight (-2.0 kg vs. -0.4 kg [saxagliptin; P < .0001]), and beta-hydroxybutyrate levels were lower than with dapagliflozin plus metformin (mean difference -0.51; P = .0009). Urinary tract/genital infections and hypoglycaemia occurred in <5.0% and 5.8% of patients, respectively, with triple therapy. Conclusions Triple therapy with once-daily dapagliflozin 5 mg, saxagliptin 5 mg and metformin significantly improved glycaemic control versus dual therapy with either agent added to metformin in uncontrolled type 2 diabetes, and was generally well tolerated.
引用
收藏
页码:2152 / 2162
页数:11
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