Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes

Inclusion Criteria

• Capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has a historical diagnosis of Type 2 diabetes mellitus (T2DM).
• Male or female and aged 18 to 75 years, inclusive.
• Body mass index (BMI) between 20 and 45 kg/m^2, inclusive.
• A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
• Is experiencing inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) concentration between 7.5% and 10%, inclusive, and has been treated with diet and exercise for at least 2 months prior to Screening. (Exception: a participant who has received any other diabetic therapy for less than 7 days in total within the 2 months prior to the screening, can be included).
• If male, has a hemoglobin >12 g/dL (>120 g/L) at Screening or if female, has a hemoglobin >10 g/dL (>100 g/L) at Screening.
• If male, has a serum creatinine 60 mL/min/1.73 m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) at Screening.
• Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary.

Exclusion Criteria

• Participated in another clinical study within 90 days prior to Screening.
• Received any investigational compound within 30 days prior to Randomization.
• Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening.
• History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
• History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Chronic pancreatitis and/or history of acute pancreatitis.
• Systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at Screening.
• History of any hemoglobinopathy or diagnosis of chronic anemia.
• New York Heart Association Class III or IV heart failure. (Participants who are stable at Class I or II and are currently treated, are candidates for the study.)
• History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
• History of any cancer, other than squamous cell or basal cell carcinoma of the skin, which has not been in full remission for at least 5 years prior to Screening. Participants with a history of treated cervical intraepithelial neoplasia [CIN] I or CIN II are allowed.
• Significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, human immunodeficiency virus or alanine aminotransferase (ALT) is 2.5 times above upper limit of normal value.
• History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB).
• History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds.
• Has used oral or systemically injected glucocorticoids (including intra-articular injection) or has used weight-loss drugs within 2 months prior to Screening. (Inhaled or topical corticosteroids were allowed.)
• History of alcohol or substance abuse within 2 years prior to Screening.
• Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs).
• History of organ transplantation.
• Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may conse