ICH GCP | Clinical Trials Registry

Takeda 

No

Inclusion Criteria: - Has a diagnosis of type 2 diabetes mellitus with either: - Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or - Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening. - Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2. - If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. - Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. - Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. - No major illness or debility that in the investigator's opinion prohibits the participant from completing the study. Exclusion Criteria: - Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg. - Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females. - Alanine aminotransferase greater than or equal to 3 times the upper limit of normal. - Calculated creatinine clearance less than or equal to 50 mL/min. - Thyroid-stimulating hormone level outside of the normal range. - History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. - History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. - History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery. - New York Heart Association Class III or IV heart failure regardless of therapy. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening. - History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. - History of infection with Human Immunodeficiency Virus. - History of a psychiatric disorder that will affect the participant's ability to participate in the study. - History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. - History of alcohol or substance abuse within the 2 years prior to Screening. - History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening. - Receipt of any investigational drug within the 30 days prior to Screening. - Prior treatment in an investigational study of alogliptin. - Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study. - Has donated more than 400 mL of blood within the 90 days preceding their participation in the study. - Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.

All

65 Years

90 Years

No

Sponsor

2008-000959-10

U1111-1112-7905

Taiwan

Randomized

Parallel Assignment

Treatment

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)