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Lookup NU author(s): Emeritus Professor Philip Home
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2017 Merck Sharp & Dohme Corp., The Authors Aims: To assess the efficacy and safety of once-weekly omarigliptin as monotherapy in people with type 2 diabetes mellitus (T2DM). Methods: People with T2DM not on glucose-lowering medications, or who were washed off monotherapy or low-dose dual therapy, were randomized double-blind to omarigliptin 25 mg (n = 165) or matching omarigliptin placebo (n = 164) for 24 weeks, followed by a 30-week period to assess continuing efficacy and safety longer-term of omarigliptin during which metformin was added to the placebo group and metformin placebo to the omarigliptin group. Results: From a mean baseline HbA1c of 8.0–8.1%, the least squares mean (95% CI) change from baseline in HbA1c at week 24 (primary endpoint) was −0.49% (−0.73, −0.24) in the omarigliptin group and −0.10% (−0.34, 0.14) in the placebo group, for a between-group difference of −0.39% (−0.59, −0.19) (p <.001). Protocol deviation in use of metformin by 38 of 252 (15%) people whose samples were available for evaluation probably attenuated glycemic efficacy results, as suggested by the LS mean difference −0.53% (−0.75, −0.32) after censoring of such participants. At 24 and 54 weeks, the incidences of adverse events (AEs) were similar in the omarigliptin and placebo groups. During 54 weeks there were no AEs of symptomatic hypoglycemia in the omarigliptin group and 5 AEs in the placebo group. Over 54 weeks, a majority of the omarigliptin treatment had a persistent reduction in HbA1c, remaining rescue-free. Conclusions: In people with T2DM, omarigliptin monotherapy improved glycemic control over 54 weeks and was generally well tolerated with a low risk of hypoglycemia. ClinicalTrials.gov Identifier: NCT01717313. EudraCT Number: 2012-003626-24.
Author(s): Home P, Shankar RR, Gantz I, Iredale C, O'Neill EA, Jain L, Pong A, Suryawanshi S, Engel SS, Kaufman KD, Lai E
Publication type: Article
Publication status: Published
Journal: Diabetes Research and Clinical Practice
Year: 2018
Volume: 138
Pages: 253-261
Print publication date: 01/04/2018
Online publication date: 24/10/2017
Acceptance date: 18/10/2017
Date deposited: 03/04/2018
ISSN (print): 0168-8227
ISSN (electronic): 1872-8227
Publisher: Elsevier Ireland Ltd
URL: https://doi.org/10.1016/j.diabres.2017.10.018
DOI: 10.1016/j.diabres.2017.10.018
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