Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

The study duration for each patient will be 27 weeks.

Inclusion criteria

• 18 to 65 years old.
• Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months:
• If on 1 OAD, provided with the following doses (including but not limited to):

• α-glucosidase inhibitor: 100mg, three times a day (tid);
• metformin: 1.5-2.0 g/day;
• sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
• thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
• Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
• If on 2-3 OADs, any range of dose is acceptable.
• HbA1c >7%, and ≤10.5%.
• FPG >7 mmol/L.
• Body mass index (BMI) ≥20 kg/m^2, and ≤40 kg/m^2.
• Diabetes duration ≥1 year.
• Physician decides to and the patient is willing to start basal insulin (BI) treatment.
• Willing to join the study and sign the informed consent.

Exclusion criteria

• Type 1 diabetes patients.
• Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
• Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
• Known hypoglycemia unawareness or recurrent hypoglycemia.
• Hypersensitivity to study drug or its excipients.
• Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
• Pregnancy or breastfeeding women.
• Have any mental disorders, lack self-control or not able to express accurately.
• Involved in another clinical trial simultaneously or within a 1 month before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.