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A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.


ABSTRACT: AIMS:To assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D). METHODS:In a 24-week double-blind trial, 414 patients with T2D were randomized to omarigliptin 25?mg once weekly, sitagliptin 50?mg once daily or placebo. The double-blind period was followed by a 28-week open-label extension during which all patients received omarigliptin 25?mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2-hour postprandial glucose (PPG) and fasting plasma glucose (FPG) levels. RESULTS:After 24?weeks, the least squares (LS) mean change from baseline in HbA1c was -0.66% for omarigliptin, -0.65% for sitagliptin and 0.13% for placebo. The difference in LS mean for omarigliptin vs placebo was -0.80% ( P ?

SUBMITTER: Gantz I 

PROVIDER: S-EPMC5655696 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.

Gantz Ira I   Okamoto Taro T   Ito Yuka Y   Okuyama Kotoba K   O'Neill Edward A EA   Kaufman Keith D KD   Engel Samuel S SS   Lai Eseng E  

Diabetes, obesity & metabolism 20170706 11


<h4>Aims</h4>To assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D).<h4>Methods</h4>In a 24-week double-blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo. The double-blind period was followed by a 28-week open-label extension during which all patients received omarigliptin 25 mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2-hour postprandial glucose (PPG)  ...[more]

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