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Saxagliptin Add-on Therapy to Insulin With or Without Metformin for Type 2 Diabetes Mellitus: 52-Week Safety and Efficacy

Background Achievement of glycemic control is an important objective in the management of type 2 diabetes mellitus (T2DM). Objective The objective of this study was to evaluate the safety and efficacy of the dipeptidyl peptidase-4 inhibitor saxagliptin versus placebo as add-on therapy in patients wi...

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Bibliographic Details
Published in:Clinical drug investigation 2013-10, Vol.33 (10), p.707-717
Main Authors: Barnett, Anthony H., Charbonnel, Bernard, Li, Jia, Donovan, Mark, Fleming, Douglas, Iqbal, Nayyar
Format: Article
Language:English
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Summary:Background Achievement of glycemic control is an important objective in the management of type 2 diabetes mellitus (T2DM). Objective The objective of this study was to evaluate the safety and efficacy of the dipeptidyl peptidase-4 inhibitor saxagliptin versus placebo as add-on therapy in patients with T2DM inadequately controlled with insulin alone or insulin plus metformin. Methods This was a long-term (28-week) extension of a short-term (24-week), randomized, double-blind, parallel-group trial of saxagliptin 5 mg once daily versus placebo as add-on therapy to open-label insulin or insulin plus metformin therapy totaling 52 weeks of treatment. In contrast with the goal of maintaining a stable insulin dosage during the short-term phase, during the extension phase the insulin dosage was flexible and adjusted as deemed appropriate by the investigator. The study was conducted in a clinical practice setting, including family practice and hospital sites. Patients with T2DM aged 18–78 years with glycated hemoglobin (HbA 1c ) 7.5–11 % on a stable insulin regimen (30–150 U/day with or without metformin) for ≥8 weeks at screening were included in the study. Patients were stratified by metformin use and randomly assigned 2:1 to oral saxagliptin 5 mg ( n  = 304) or placebo ( n  = 151) once daily. All patients who completed the initial 24 weeks of treatment were eligible to participate in the 28-week extension, regardless of whether they had required rescue treatment. The main outcome measure was change in HbA 1c from baseline to week 52. Results In general, the outcomes achieved at week 24 were sustained to week 52. Adjusted mean change from baseline HbA 1c at week 52 was greater with saxagliptin (−0.75 %) versus placebo (−0.38 %); the adjusted between-group difference was −0.37 % (95 % CI −0.55 to −0.19); between-group differences were similar in patients treated with metformin (−0.37 % [95 % CI −0.59 to −0.15]) and without metformin (−0.37 % [95 % CI −0.69 to −0.04]). At week 52, a greater proportion of patients receiving saxagliptin achieved HbA 1c
ISSN:1173-2563
1179-1918
DOI:10.1007/s40261-013-0107-8