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Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes
被引:129
作者:
Mathieu, Chantal
[1
]
Ranetti, Aurelian Emil
[2
]
Li, Danshi
[3
]
Ekholm, Ella
[4
]
Cook, William
[5
]
Hirshberg, Boaz
[6
]
Chen, Hungta
[5
]
Hansen, Lars
[3
]
Iqbal, Nayyar
[3
]
机构:
[1] Katholieke Univ Leuven, Leuven, Belgium
[2] Carol Davila Univ Med & Pharm, Bucharest, Romania
[3] Bristol Myers Squibb Co, Princeton, NJ USA
[4] AstraZeneca, Molndal, Sweden
[5] AstraZeneca, Gaithersburg, MD USA
[6] MedImmune, Gaithersburg, MD USA
关键词:
INADEQUATE GLYCEMIC CONTROL;
DIPEPTIDYL PEPTIDASE-4 INHIBITOR;
CLINICAL-TRIALS;
BODY-WEIGHT;
EFFICACY;
SAFETY;
24-WEEK;
SULFONYLUREA;
MELLITUS;
PIOGLITAZONE;
D O I:
10.2337/dc15-0779
中图分类号:
R5 [内科学];
学科分类号:
1002 ;
100201 ;
摘要:
OBJECTIVE To compare the efficacy and safety of treatment with dapagliflozin versus that with placebo add-on to saxagliptin plus metformin in patients whose type 2 diabetes is inadequately controlled with saxagliptin plus metformin treatment. RESEARCH DESIGN AND METHODS Patients receiving treatment with stable metformin (stratum A) (screening HbA(1c) level 8.0-11.5% [64-102 mmol/mol]) or stable metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor (stratum B) (HbA(1c) 7.5-10.5% [58-91 mmol/mol]) for >= 8 weeks received open-label saxagliptin 5 mg/day and metformin for 16 weeks (stratum A) or 8 weeks (stratum B) (saxagliptin replaced any DPP-4 inhibitor). Patients with inadequate glycemic control (HbA(1c) 7-10.5% [53-91 mmol/mol]) were randomized to receive placebo or dapagliflozin 10 mg/day plus saxagliptin and metformin. The primary end point was the change in HbA(1c) from baseline to week 24. Secondary end points included fasting plasma glucose (FPG) level, 2-h postprandial glucose (PPG) level, body weight, and proportion of patients achieving an HbA(1c) level of <7% (53 mmol/mol). RESULTS Treatment with dapagliflozin add-on to saxagliptin plus metformin resulted in a greater mean HbA(1c) reduction than placebo (-0.82 vs. -0.10% [-9 vs. -1.1 mmol/mol], P < 0.0001). Significantly greater reductions in FPG level, 2-h PPG level, and body weight were observed, and more patients achieved an HbA(1c) level of < 7% (53 mmol/mol) with treatment with dapagliflozin versus placebo. Adverse events were similar across treatment groups, with a low overall risk of hypoglycemia (similar to 1%). Genital infections developed in more patients with dapagliflozin treatment (5%) than with placebo (0.6%). CONCLUSIONS Triple therapy with dapagliflozin add-on to saxagliptin plus metformin improves glycemic control and is well tolerated in patients whose type 2 diabetes is inadequately controlled with saxagliptin plus metformin therapy.
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页码:2009 / 2017
页数:9
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