START-J：高齢者を対象とした日本の臨床試験

基本情報

NCT ID

NCT01183104

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

305

治験依頼者名

Japan Association for Diabetes Education and Care

概要

The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)