Status:
COMPLETED
Initiation and Titration of Amaryl
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT01144728
Start Date
May 1 2010
End Date
December 1 2010
Last Update
January 31 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Almaty, Kazakhstan