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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)
サノフィ株式会社(INDUSTRY)