Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) (GREAT)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GLIMEPIRIDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908921

GLIME_L_04409

Details and patient eligibility

About

To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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391 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: GLIMEPIRIDE