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

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)

Timeline

Start

2012-02

Primary completion

2013-05

Completion

2013-05

Drugs

Indications