Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
172 participants
INTERVENTIONAL
2010-05-31
2010-12-31
Brief Summary
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* 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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm Glimepiride+metformin
Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
GLIMEPIRIDE + METFORMIN
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
Interventions
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GLIMEPIRIDE + METFORMIN
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Almaty, , Kazakhstan
Countries
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Other Identifiers
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U1111-1116-9956
Identifier Type: OTHER
Identifier Source: secondary_id
GLMET_L_04718
Identifier Type: -
Identifier Source: org_study_id