Initiation and Titration of Amaryl

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Metformin

Criteria

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.