The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.

The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.

The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.

Total of all reporting groups

This baseline characteristic was analyzed only in female participants.

Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment).

Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was listed as "unknown." Normal: >=90 milliliter per minute (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2 Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2. eGFR = 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female), where Cr is serum creatinine.

This baseline characteristic was analyzed only in participants who had diabetic complications. Participants may be represented in more than 1 category.

Liver damage complications were categorized as hepatic steatosis, hepatitis alcoholic, chronic hepatitis, hepatic cirrhosis and any other complications related to liver damage. This baseline characteristic was analyzed only in participants who had complications of liver damage. Participants may be represented in more than 1 category.

Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and a higher severity grade for either AST or ALT serum levels was adopted. Normal: <50 international units per liter (IU/L), Grade 1: >=50 to <100 IU/L, Grade 2: >=100 to <500 IU/L, and Grade 3: >=500 IU/L.

Renal damage complications were categorized as nephrotic syndrome, glomerulonephritis, renal failure chronic and any other complications related to renal damage. This baseline characteristic was analyzed only in participants who had renal damage complications. Participants may be represented in more than 1 category.

Heart disease complications were categorized as cardiac failure, myocardial infarction, angina pectoris, and any other complications related to heart disease. This baseline characteristic was analyzed only in participants who had heart disease complications. Participants may be represented in more than 1 category.

NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). This baseline measure was analyzed only for participants who had complications of heart failure.

This baseline characteristic was analyzed only in participants who had complications of stroke-related disease.

Participants who had complications other than diabetic, hypertension, dyslipidemia, hyperuricemia, liver damage, renal damage, heart disease, heart failure, stroke-related disease, allergic disease, and malignant tumor were analyzed in this measure.

In this measure, participants responded whether they consumed alcohol-containing beverages nearly every day or not.

Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.

Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.

The safety analysis set was defined as all participants who completed the study and had safety data available.

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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.

The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.

The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.

The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.

The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.

The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.

Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.