Exploratory study to assess glycemic control through CGM in patients with type 2 diabetes treated with basal insulin randomized to insulin Glargine 300U / ml or Glargine 100 U / ml: a 21-week single site study with parallel arms.

CPCLIN - Centro de Pesquisas Clinicas LTDA0 个研究点开始时间: 2020年1月28日最近更新: 2023年5月29日

试验速览

暂无简介。

•Subjects with type 2 diabetes greater than 18 years of age with 1 or more oral antidiabetic agents (metformin and / or sulfonylurea) and NPH baseline insulin for at least 6 months;
•HbA1c between ?7.5% and ?11%);
•Capable and agreeing subjects to perform capillary glycemia;
•Subjects who were able and who agreed to use CGM during the study;
•Subjects who signed an Informed Consent Form.

•Under 18 years of age;
•Subjects with type 1 diabetes mellitus
•Subjects on an insulin regimen at baseline / bolus or pre-admixture or with another oral antidiabetic other than metformin or sulphonylurea.
•History of hypoglycemia without symptoms.
•Known hypersensitivity to insulin glargine or to one of its excipients
•Carrier of any clinical condition including alcohol abuse or psychiatric condition) or known illness that prevents the subject from adhering to the protocol.
•Use of systemic glucocorticoids for 2 weeks or longer than 12 weeks prior to screening (excluding topical or inhaled).
•Pregnant or breastfeeding women
•Women who do not want contraception.
•Participants from another clinical study.
•Subject with a history of cancer in the last 5 years except for basal cell cancer
•Company employees
•Night workers

发起方

CPCLIN - Centro de Pesquisas Clinicas LTDA