Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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