Primary Objective:

To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%.

Secondary Objectives:

The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10 mmol/L).

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.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org