Initiation and Titration of Amaryl
- Registration Number
- NCT01144728
- Lead Sponsor
- Sanofi
- 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
* tolerability (number and severity of hypoglycaemia)
Secondary Objective:
* Fasting Plasma Glucose
* Weight evolution
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Glimepiride+metformin GLIMEPIRIDE + METFORMIN Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
- Primary Outcome Measures
Name Time Method Glycolysated Haemoglobin (HbA1c) From baseline to Month 4 Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% Month 4 Evolution of Fasting Plasma Glucose (FPG) From baseline to Months 4
- Secondary Outcome Measures
Name Time Method Post Prandial Plasma Glucose (PPPG) Month 4 Number of patients for each start dose At baseline Number of patients with different final doses Month 4 Rate of Symptomatic Hypoglycemia During treatment period (4 months) Change in Weight Month 4
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇰🇿Almaty, Kazakhstan