Exploratory study to assess blood sugar control through the continuous use glucose monitor in patients with type 2 diabetes treated with basal insulin randomized to insulin glargine 300u / ml or glargine 100 u / ml been a 21 week single site study open with parallel arms
- Conditions
- Diabetes mellitus insulino-dependente
- Registration Number
- RBR-35nvnj
- Lead Sponsor
- CPCLIN - Centro de Pesquisas Clinicas LTDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method