Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
GREAT
1 other identifier
interventional
391
1 country
1
Brief Summary
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 26, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 8, 2012
August 1, 2012
1.4 years
May 26, 2009
August 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycosylated hemoglobin (HbA1c) rate
week 16
Secondary Outcomes (3)
Fasting Plasma Glucose (FPG) rate
week 16
Post Prandial Glucose (PPG) rate
week 16
Percentage of patients achieving HbA1c <7.0
week 16
Study Arms (1)
1
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Shanghai, China
Related Publications (1)
Guo XH, Lv XF, Han P, Zhang XZ, Yang HZ, Duan WR, Gao Y. Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus. Curr Med Res Opin. 2013 Mar;29(3):169-74. doi: 10.1185/03007995.2013.765396. Epub 2013 Jan 24.
PMID: 23305037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mei Mao
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2009
First Posted
May 27, 2009
Study Start
April 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
August 8, 2012
Record last verified: 2012-08