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1型糖尿病の小児および青年におけるHOE901-U300とランタスの安全性および有効性の比較
基本情報
- NCT ID
- NCT02735044
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 463
- 治験依頼者名
- Sanofi
概要
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: * Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). * To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
対象疾患
Type 1 Diabetes Mellitus
介入
Insulin glargine,300 U/mL(DRUG)
Insulin glargine (100 units /mL)(DRUG)
Background therapy(DRUG)
依頼者（Sponsor）
サノフィ株式会社(INDUSTRY)