drugset / Trial / NCT00272077

Insulin Glargine in Type 2 Diabetes Mellitus

NCT00272077 ↗

Phase 4 Completed Sanofi
RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective: To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose). Secondary objectives: The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.

Timeline

Start
2005-04
Primary completion
2006-05
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — —