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

Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.

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)

6 months

Inclusion criteria :

• T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
• Males and Female > 18 years
• HbA1c > 7.5%
• Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
• It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment

Exclusion criteria :

• Type 1 diabetes
• Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
• Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
• Patient planning a pregnancy now or in the next 6 months
• The patient is participating in another clinical study now or in the last 28 days prior to Visit 1
• The patient is a drug user (currently or in the past)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.