Initiation and Titration of Amaryl

AMIT Study - Amaryl M Initiation and Titration Study

Primary Objective:

• To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
• initial dose
• titration scheme
• efficacy after 4 months assessed by HbA1C
• tolerability (number and severity of hypoglycaemia)

Secondary Objective:

• Fasting Plasma Glucose
• Weight evolution

Inclusion criteria:

• Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
• sulfonylurea monotherapy or
• metformin monotherapy or
• free combination of glimepiride and metformin with a stable dose (any dose)
• Body Mass Index (BMI) between 20 and 40 kg/m2
• HbA1c superior or egal to 7.5%
• FPG superior or egal 7 mmol/l

Exclusion criteria:

• Secondary or insulin-dependant diabetes
• Any severe chronic disease (hepatic, renal impairments)
• History of major cardiovascular event in the last 6 months
• Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
• Allergy to sulfonylurea, metformin
• Drug or alcohol abuse
• Pregnancy, lactation

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