Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes

Inclusion Criteria

• Diagnosed with type 2 diabetes mellitus.
• Had an HbA1c of ≥ 6.5% and 2.4 mg/dL (men) or >2.0 mg/dL (women) at the start of the observation period (Week -2)].
• Obvious clinical manifestations of hepatic impairment [e.g., an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value of ≥ 2.5 times the upper limit of normal at the start of the observation period (Week -2)].
• Any serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease (e.g., requiring hospitalization for treatment).
• Systolic blood pressure of ≥ 180 mmHg or diastolic blood pressure of ≥ 110 mmHg during the observation period.
• A condition requiring insulin for blood glucose control (e.g., a patient with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, a pre- or post-operative condition, or serious trauma).
• Malignant tumor.
• History of hypersensitivity or allergies to dipeptidyl-peptidase-4 (DPP-4) inhibitors.
• A habitual drinker whose daily alcohol consumption was >100 mL on average.
• A history of drug abuse (defined as any illicit drug use) or alcohol abuse.
• Required to take excluded medications during the duration of the study.
• Previously received SYR-322 or Nesina® Tablets in a clinical study or as a therapeutic drug.
• Received any investigational product (including investigational products for postmarketing clinical studies) within 12 weeks prior to the start of the observation period.
• Had participated in another clinical study at signing of informed consent.
• If female, was pregnant or lactating, or intended to become pregnant between signing of informed consent and 1 month after the end of the study; or intended to donate ova during such time period.
• A study site employee, an immediate family member of a study site employee or in a dependent relationship with a study site employee who was involved in the conduct of this study (e.g., spouse, parent, child, sibling), or might consent under duress.
• Changed the dosing regimen of the ongoing rapid-acting insulin secretagogue during the observation period.
• History of hypersensitivity or allergies to rapid-acting insulin secretagogues.
• Any condition for which Nesina® Tablets, nateglinide, or mitiglinide calcium hydrate was contraindicated as defined in their package inserts.
• Otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion.