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Randomized, Double-Blind Trial of Triple Therapy With Saxagliptin Add-on to Dapagliflozin Plus Metformin in Patients With Type 2 Diabetes
- Source :
- Diabetes care. 38(11)
- Publication Year :
- 2015
-
Abstract
- OBJECTIVE The objective of this study was to assess the efficacy and safety of triple therapy with saxagliptin add-on versus placebo add-on to dapagliflozin plus metformin in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS Patients on stable metformin (≥1,500 mg/day) for ≥8 weeks with glycated hemoglobin (HbA1c) 8.0–11.5% (64–102 mmol/mol) at screening received open-label dapagliflozin (10 mg/day) plus metformin immediate release (IR) for 16 weeks. Patients with inadequate glycemic control (HbA1c 7–10.5% [53–91 mmol/mol]) were then randomized to receive placebo (n = 153) or saxagliptin 5 mg/day (n = 162) in addition to background dapagliflozin plus metformin IR. The primary efficacy end point was change in HbA1c from baseline to week 24. RESULTS There was a significantly greater reduction in HbA1c at 24 weeks with saxagliptin add-on (–0.51% [–5.6 mmol/mol]) versus placebo (–0.16% [–1.7 mmol/mol]) add-on to dapagliflozin plus metformin (difference, –0.35% [95% CI –0.52% to –0.18%] and –3.8 [–5.7 to –2.0 mmol/mol], respectively; P < 0.0001). Reductions in fasting plasma glucose and 2-h postprandial glucose were similar between treatment arms. A larger proportion of patients achieved HbA1c CONCLUSIONS Triple therapy with the addition of saxagliptin to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with type 2 diabetes inadequately controlled with dapagliflozin plus metformin.
- Subjects :
- Adult
Blood Glucose
Male
medicine.medical_specialty
endocrine system diseases
Endocrinology, Diabetes and Metabolism
Urology
Adamantane
Type 2 diabetes
Hypoglycemia
Saxagliptin
Placebo
chemistry.chemical_compound
Double-Blind Method
Glucosides
Internal medicine
Diabetes mellitus
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Dapagliflozin
Benzhydryl Compounds
Aged
Advanced and Specialized Nursing
Glycated Hemoglobin
business.industry
nutritional and metabolic diseases
Dipeptides
Middle Aged
medicine.disease
Metformin
Endocrinology
Treatment Outcome
chemistry
Diabetes Mellitus, Type 2
Drug Therapy, Combination
Female
Glycated hemoglobin
business
medicine.drug
Subjects
Details
- ISSN :
- 19355548
- Volume :
- 38
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Diabetes care
- Accession number :
- edsair.doi.dedup.....a3aa5260c3d7f1318b333f347267acdc