Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial.
Summary of "Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial."
Aim:â€‚ 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:â€‚ A total of 858 patients [age â‰¥â€ƒ18â€ƒyears; glycated haemoglobin (HbA(1c) ) >â€ƒ6.5â€Š-â€Š10.0%; on stable metformin doses â‰¥â€ƒ1500â€ƒmg/day] were randomised 1â€ƒ:â€ƒ1 to saxagliptin 5â€ƒmg/day or glipizide up-titrated as needed from 5 to 20â€ƒmg/day for 52â€ƒweeks. The primary objective was to assess if the change from baseline HbA(1c) achieved with saxagliptin plus metformin was non-inferior to glipizide plus metformin. Results:â€‚ The per-protocol analysis demonstrated non-inferiority of saxagliptin vs. glipizide; adjusted mean changes from baseline HbA(1c) 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%; pâ€ƒ<â€ƒ0.0001) and a divergent impact on body weight (adjusted mean change from baseline -1.1â€ƒkg with saxagliptin vs. 1.1â€ƒkg with glipizide; pâ€ƒ<â€ƒ0.0001). There was a significantly smaller rise in HbA(1c) (%/week) from week 24 to 52 with saxagliptin vs. glipizide (0.001% vs. 0.004%; pâ€ƒ=â€ƒ0.04) indicating a sustained glycaemic effect beyond week 24. Excluding hypoglycaemic events, the proportion of patients experiencing adverse events (AEs) was similar (60.0% saxagliptin vs. 56.7% glipizide); treatment-related AEs were less common with saxagliptin vs. glipizide (9.8% vs. 31.2%), attributable to the higher frequency of hypoglycaemia in glipizide patients. Discontinuation rates resulting from AEs were similar (âˆ¼4%). Conclusion:â€‚ Saxagliptin plus metformin was well tolerated, provided a sustained HbA(1c) reduction over 52â€ƒweeks, and was non-inferior to glipizide plus metformin, with reduced body weight and a significantly lower risk of hypoglycaemia.
Hospital of the Ludwig Maximilian, University of Munich, Munich, Germany Klinikum der Eberhard-Karls-UniversitÃ¤t TÃ¼bingen Medizinische Klinik, TÃ¼bingen, Germany Helsinki University Central Hospital, Unit of General Practice and University of Helsinki,
This article was published in the following journal.
Name: International journal of clinical practice
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20846286
- DOI: http://dx.doi.org/10.1111/j.1742-1241.2010.02510.x
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Medical and Biotech [MESH] Definitions
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.