Overview

Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective: - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives: - To evaluate the percentage of patients with Hb A1c < 7.5%, - To evaluate the rate of hypoglycaemia (symptomatic, severe) - To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment - To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment - To assess the overall safety - To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin, Globin Zinc