Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT00908921
Last Updated: 2012-08-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
391 participants
INTERVENTIONAL
2009-04-30
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
GLIMEPIRIDE
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GLIMEPIRIDE
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1C more than 7.5 and less than 11.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mei Mao
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GLIME_L_04409
Identifier Type: -
Identifier Source: org_study_id