Clinical trial NCT00707993 (phase 3, status: completed)
Conditions: diabetes mellitus
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9
Drugs: alogliptin, glipizide
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=NC=C(N=C1)C(=O)NCCC1=CC=C(C=C1)S(=O)(=O)NC(=O)NC1CCCCC1
Eligibility criteria:

        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.