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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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Published in: | Clinical drug investigation 2013-10, Vol.33 (10), p.707-717 |
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Main Authors: | , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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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 |
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ISSN: | 1173-2563 1179-1918 |
DOI: | 10.1007/s40261-013-0107-8 |