Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin:a randomized, double-blind, placebo-controlled 102-week trial

Bailey, Clifford J., Gross, Jorge L., Hennicken, Delphine, Iqbal, Nayyar, Mansfield, Traci A. and List, James F. (2013). Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin:a randomized, double-blind, placebo-controlled 102-week trial. BMC Medicine, 11 (1),

Abstract

Background: Management of type 2 diabetes with metformin often does not provide adequate glycemic control, thereby necessitating add-on treatment. In a 24-week clinical trial, dapagliflozin, an investigational sodium glucose cotransporter 2 inhibitor, improved glycemic control in patients inadequately controlled with metformin. The present study is an extension that was undertaken to evaluate dapagliflozin as long-term therapy in this population.Methods: This was a long-term extension (total 102 weeks) of a 24-week phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group trial. Patients were randomly assigned (1:1:1:1) to blinded daily treatment (placebo, or dapagliflozin 2.5 to 5, or 10 mg) plus open-label metformin (=1,500 mg). The previously published primary endpoint was change from baseline in glycated hemoglobin (HbA1c) at 24 weeks. This paper reports the follow-up to week 102, with analysis of covariance model performed at 24 weeks with last observation carried forward; a repeated measures analysis was utilized to evaluate changes from baseline in HbA1c, fasting plasma glucose (FPG), and weight.Results: A total of 546 patients were randomized to 1 of the 4 treatments. The completion rate for the 78-week double-blind extension period was lower for the placebo group (63.5%) than for the dapagliflozin groups (68.3% to 79.8%). At week 102, mean changes from baseline HbA1c (8.06%) were +0.02% for placebo compared with -0.48% (P = 0.0008), -0.58% (P

Publication DOI: https://doi.org/10.1186/1741-7015-11-43
Divisions: Life & Health Sciences > Biosciences
Life & Health Sciences > Chronic and Communicable Conditions
Life & Health Sciences
Additional Information: © 2013 Bailey et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Uncontrolled Keywords: dapagliflozin,metformin,SGLT2,sodium-glucose cotransporter 2,glycemic control,type 2 diabetes
Full Text Link: http://www.biom ... 1741-7015/11/43
http://www.biom ... 741-7015/11/193
http://www.scop ... tnerID=8YFLogxK
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
Published Date: 2013-02-20
Authors: Bailey, Clifford J. ( 0000-0002-6998-6811)
Gross, Jorge L.
Hennicken, Delphine
Iqbal, Nayyar
Mansfield, Traci A.
List, James F.

Download

[img]

Version: Published Version

License: Creative Commons Attribution


[img]

Version: Published Version


Export / Share Citation


Statistics

Additional statistics for this record