Diabetes mellitus insulino-dependente
Conditions
Interventions
After screening (V1), eligible subjects will remain in a 4-week follow-up period during which NPH insulin will be optimized and patients using sulfonilurea on V1 will have this medication discontinued
Drug
Sponsors
CPCLIN - Centro de Pesquisas Clinicas LTDA
CPCLIN - Centro de Pesquisas Clinicas LTDA
Eligibility
Age
18 Years to 100 Years
Inclusion 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
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. Subject with a history of cancer in the last 5 years except for basal cell cancer Company employees Night workers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: (Efficacy) Estimate percentage of time the patient remained in the blood glucose range between 70-180 mg / dl at week 11-12 and 12-13 at the end of the titration period using data collected by GCM Glycemic Profile at week 1-2, 11-12 and 12-13; Maintained blood glucose time between 70-180 mg / dl in hypoglycemia and hyperglycemia; Time to reach 100 mg / dl target;Expected Outcome 2: (Safety) Adverse Events and Serious Adverse Events;Expected Outcome 3: (Safety) Patient-reported hypoglycemia captured at V1 visits until last visit, with hypoglycemia being defined as CG <70 mg / dL or typical symptoms that are reversed by glucose or glucagon. Severe hypoglycemia is defined as a hypoglycemic event for which the subject needs assistance from another person. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: MAGE parameters, mean amplitude of glycemic excursions;Expected Outcome 2: Average Time Parameters to reach 100 mg / dl target;Expected Outcome 3: Parameters of Percentage time in hypoglycemia obtained by GCM defined as less than 70 mg / dl;Expected Outcome 4: Parameters of Percentage time in hypoglycemia obtained by GCM defined as less than or equal to 54 mg / d;Expected Outcome 5: Parameters Percentage of time in hyperglycemia obtained by GCM defined as greater than or equal to 180 mg / dl;Expected Outcome 6: Proportion Parameters of Patients Having Hypoglycemia While Using GCM;Expected Outcome 7: Proportion Parameters of Patients Having Night Hypoglycemia (12:00 AM to 5:59 AM) During CGM Use;Expected Outcome 8: Parameters of Glycated Hemoglobin Variation Between V1 and Week 12;Expected Outcome 9: Fasting Blood Glucose Parameters Between V1 and Week 12;Expected Outcome 10: Parameters of Gla-100 and Gla 300 Insulin Dose Range between V1 and Week 13;Expected Outcome 11: Parameters of Body Weight Variation Between V1 and Week 13 | — |
Countries
Brazil
Contacts
Public ContactDenise Franco
CPCLIN - Centro de Pesquisas Clinicas LTDA
Outcome results
None listed