Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Status:
Completed
Trial end date:
2020-06-29
Target enrollment:
Participant gender:
Summary
Primary Objective:
To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily
premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction
from baseline to end of study. The test for superiority can be done if noninferiority is
achieved.
Secondary Objectives:
- To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7%
without hypoglycemia.
- To assess efficacy in terms of percentage of patients achieving fasting plasma glucose
(FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.
- To assess safety in term of occurrence of moderate/severe hypoglycemia.
- To assess daily blood glucose (BG) variation.
- To assess patient satisfaction.