The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

No participant was experienced the dose adjustment (dose escalation or dose reduction).