Diabetes Mellitus, Type 2
Conditions
Brief summary
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.
Interventions
DRUGGLIMEPIRIDE
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycosylated hemoglobin (HbA1c) rate | week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose (FPG) rate | week 16 |
| Post Prandial Glucose (PPG) rate | week 16 |
| Percentage of patients achieving HbA1c <7.0 | week 16 |
Countries
China
Outcome results
None listed