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Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial
- Source :
- International Journal of Clinical Practice. 64:1619-1631
- Publication Year :
- 2010
- Publisher :
- Hindawi Limited, 2010.
-
Abstract
- Summary Aim: To assess the efficacy and safety of saxagliptin vs. glipizide as add-on therapy to metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone. Methods and patients: A total of 858 patients [age ≥ 18 years; glycated haemoglobin (HbA1c) > 6.5 – 10.0%; on stable metformin doses ≥ 1500 mg/day] were randomised 1 : 1 to saxagliptin 5 mg/day or glipizide up-titrated as needed from 5 to 20 mg/day for 52 weeks. The primary objective was to assess if the change from baseline HbA1c achieved with saxagliptin plus metformin was non-inferior to glipizide plus metformin. Results: The per-protocol analysis demonstrated non-inferiority of saxagliptin vs. glipizide; adjusted mean changes from baseline HbA1c were −0.74% vs. −0.80%, respectively; the between-group difference was 0.06% (95% CI, −0.05% to 0.16%). Treatment with saxagliptin vs. glipizide was associated with a significantly smaller proportion of patients with hypoglycaemic events (3.0% vs. 36.3%; p
- Subjects :
- medicine.medical_specialty
endocrine system diseases
medicine.drug_class
030209 endocrinology & metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
Saxagliptin
Lower risk
Gastroenterology
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Medicine
Adverse effect
business.industry
nutritional and metabolic diseases
General Medicine
medicine.disease
Sulfonylurea
3. Good health
Discontinuation
Metformin
Endocrinology
chemistry
business
Glipizide
medicine.drug
Subjects
Details
- ISSN :
- 13685031
- Volume :
- 64
- Database :
- OpenAIRE
- Journal :
- International Journal of Clinical Practice
- Accession number :
- edsair.doi...........30e0c0d32a94a3f3d7640ff7ec396722