Intervention: Pioglitazone
Trial phase: Phase 3
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.
A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.
No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.
A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2.
Fasting C-peptide greater than or equal to 0.8 ng/mL.
Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.
Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.
Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.
Females of childbearing potential who are sexually active must agree to use adequate 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 prohibited the patient from completing the study.

Exclusion Criteria:

Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.
A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
A history of treated diabetic gastroparesis.
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.
History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
History of a psychiatric disorder that could have affected the patient's ability to participate in the study.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
A history of alcohol or substance abuse within 2 years prior to Screening.
Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
Previous participation in an investigational study of alogliptin.
Hypersensitive to pioglitazone, alogliptin, or other excipients.