🏥 治験ポータル
← 治験一覧に戻る

日本人2型糖尿病患者におけるインスリングラルギン/リキシセナチド固定比率配合剤の食後血糖動態反応

基本情報

NCT ID
NCT02713477
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
20
治験依頼者名
Sanofi

概要

Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

対象疾患

Type 2 Diabetes Mellitus

介入

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010(DRUG)
Insulin glargine HOE901(DRUG)
Placebo(DRUG)

依頼者(Sponsor)