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Predicting steady‐state HbA 1c responses to sitagliptin in patients with type 2 diabetes mellitus *
Author(s) -
Kanazu S.,
Horie Y.,
Narukawa M.,
aka K.,
Taniguchi T.,
Arjona Ferreira J. C.,
Takeuchi M.
Publication year - 2009
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/j.1463-1326.2009.01058.x
Subject(s) - sitagliptin , medicine , diabetes mellitus , endocrinology , type 2 diabetes mellitus , type 2 diabetes , dipeptidyl peptidase 4 inhibitor , gastroenterology
Aims: To develop predictive formulas using short‐term changes in glycaemic parameters [haemoglobin A 1c (HbA 1c ) and fasting plasma glucose (FPG)] with sitagliptin, a highly selective dipeptidyl peptidase‐4 inhibitor, to assess longer term steady‐state changes in HbA 1c . Methods: Results from two, 12‐week, double‐blind studies of sitagliptin in Japanese patients with type 2 diabetes mellitus receiving once‐daily sitagliptin 100 mg were used to construct linear models to develop predictive formulas based on study 1 (S1) and to validate them using study 2 (S2). HbA 1c and FPG were the primary and the key secondary end‐point for both studies and were both used to develop predictive formulas. Results: The predictive formulas using HbA 1c ± FPG results (slope of change) from week 0 to week 4 in S1 showed high correlations between fitted and observed week 12 HbA 1c : for HbA 1c alone R 2 = 0.76, for HbA 1c + FPG R 2 = 0.89. When using the sitagliptin 100 mg group of S2 data set to assess the validity of the predictive formulas, high correlations for HbA 1c alone (R 2 = 0.76) and for HbA 1c + FPG (R 2 = 0.77) were also observed. Data using a lower dose (25 mg once daily) of sitagliptin also demonstrated similar results. Conclusions: The early responses (over 4 weeks) in HbA 1c and FPG with sitagliptin can be used to accurately predict later responses (at week 12) in HbA 1c in Japanese patients with type 2 diabetes mellitus. Additional studies applying this approach to other agents with diverse mechanisms are important.