RBR-35nvnj
Completed
Phase 4
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 sitesJanuary 28, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CPCLIN - Centro de Pesquisas Clinicas LTDA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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