Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.

Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.

The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter

Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values and who were not excluded due to non-compliance.

The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.

Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 last observation carried forward (LOCF) results who were not excluded due to non-compliance.

Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.

Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.

SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.

Treated participants; All participants who took at least one dose of double-blind study medication in the treatment group they were randomized to unless participants had never received the double-blind study medication they were randomized. Those participants were included in the treatment group based on the first treatment received.