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Treat‐to‐target trials: uses, interpretation and review of concepts
Author(s) -
Garber A. J.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12129
Subject(s) - insulin aspart , medicine , insulin glargine , insulin degludec , insulin detemir , type 2 diabetes , hypoglycemia , randomized controlled trial , clinical endpoint , weight gain , diabetes mellitus , insulin , endocrinology , body weight
Treat‐to‐target trial designs compare investigational insulins with a standard insulin. Treat‐to‐target trials force‐titrate insulin dosages to achieve a prespecified treatment goal. With comparable glycaemic control, comparisons of safety endpoints such as hypoglycaemia can be made to establish the risk‐benefit profile of the new insulin. Glargine versus NPH showed comparable A1C reductions; however, A1C <7% without associated nocturnal hypoglycaemia was reached in more patients on glargine and overall hypoglycaemia was lower. Detemir versus glargine showed non‐inferiority between the groups; however, with less weight gain and more injection site reactions with detemir. Detemir/aspart versus glargine/aspart showed non‐inferiority between the treatments, however, with less weight gain in the detemir group but comparable risk of hypoglycaemia. Degludec in combination with aspart versus glargine/aspart showed comparable A1C reductions. However, degludec‐treated patients had less overall hypoglycaemia and less nocturnal hypoglycaemia. Because insulin titrations are guided by goal attainment with each treatment, treat‐to‐target trials enable clinicians to determine differences in non‐glycaemic treatment effects, such as rates of hypoglycaemia and weight gain, at the same level of glycaemic control.