- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00908921
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) (GREAT)
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Shanghai, China
- Sanofi-Aventis Administrative Office
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed <6 months and who had not taken oral antidiabetic medication or insulin for >3months.
- HbA1C more than 7.5 and less than 11.
Exclusion Criteria:
- Fasting plasma glucose of >13.5mmol/L
- Type 1 Diabetes Mellitus (T1DM)
- Patient with acute illness hospitalized in last 2 months
- Patient with active liver disease, impaired renal or hepatic functions
- Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
- Pregnant and lactating women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg. At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg. Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion. |
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in glycosylated hemoglobin (HbA1c) rate
Time Frame: week 16
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week 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting Plasma Glucose (FPG) rate
Time Frame: week 16
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week 16
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Post Prandial Glucose (PPG) rate
Time Frame: week 16
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week 16
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Percentage of patients achieving HbA1c <7.0
Time Frame: week 16
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week 16
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mei Mao, Sanofi
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLIME_L_04409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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