Study: NCT01768559

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lixisenatide (AVE0010)
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin glulisine QD
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin glulisine TID
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin Glargine (Mandatory background drug)
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin Glargine (Mandatory background drug)
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Insulin Glargine (Mandatory background drug)
Description: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin (Background drug)
Description: Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin (Background drug)
Description: Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin (Background drug)
Description: Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.