临床试验/ISRCTN56991780

ISRCTN56991780已完成未知

Initiation of insulin glargine 300 U/mL in type 2 diabetic patients after failure of pre-existing BOT treatment with any other basal insulin

Sanofi-Aventis Deutschland GmbH0 个研究点目标入组 3,000 人开始时间: 2019年7月3日最近更新: 2022年10月10日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: Sanofi-Aventis Deutschland GmbH
入组人数: 3,000

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2016 Abstract results in https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0036-1580971 conference abstract 2018 Abstract results in https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0038-1641918 conference abstract 2018 Abstract results in https://diabetes.diabetesjournals.org/content/67/Supplement_1/1020-P conference abstract 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30302721/ (added 19/04/2021) 2021 Results article in https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14549 (added 09/08/2022)

研究设计

研究类型: Observational

入排标准

性别: All

入选标准

•1. Patients with type 2 diabetes (basal insulin and oral antidiabetic drugs) with any basal insulin except insulin glargine 300 U/mL
•2. Adults and seniors: age at least 18 years, no upper age limit
•3. HbA1c between 7.5% to 10.0%
•4. Fasting blood glucose > 130 mg/dL
•5. Ability and willingness to perform blood glucose self-monitoring

排除标准

•1. Type 1 diabetes
•2. Contraindications for therapy with insulin glargine 300 U/mL
•3. Existing insulin therapy with basal and bolus Insulin (i.e. basal-bolus insulin therapy, premixed insulin therapy)
•4. Patients with known cancer disease
•5. Pregnancy
•6. Drug or alcohol abuse
•7. Dementia or general incapacity to understand the content of the observational study

研究者

发起方

Sanofi-Aventis Deutschland GmbH

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