Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:

Subject was newly diagnosed (ie, had not received any treatment).
Subject was treated with diet and exercise alone for the 3 months prior to Screening
Subject had received <7 continuous days of any antidiabetic therapy within the 3 months prior to Screening.
Subject had a diagnosis of type 2 diabetes mellitus based on current American Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose tolerance test at 2 hours after administration of the glucose load must have been ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL.
Body mass index ≥23 kg/m2 and ≤40 kg/m2.
Fasting C-peptide concentration ≥0.8 ng/mL.
Glycosylated hemoglobin concentration between 6.8% and 11.0%.
Fasting plasma glucose >126 mg/dL at Screening.

No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:

Other antidiabetic agents
Investigational antidiabetic agents
Niacin
Regular use of systemic glucocorticoids.
No treatment within the 3 months prior to Screening with weight-loss drugs
If taking other non-excluded medications, must have been on a stable dose of medication for at least 4 weeks.
Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.
Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception.
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 subject from completing the study.
Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.
Hepatic transaminase ≤2 x upper limit of normal.

Exclusion Criteria:

History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening.
History of proteinuria >1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio >1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week.
Serum creatinine ≥2.0 mg/dL.
History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy.
History of treated peripheral or autonomic neuropathy.
History of systolic dysfunction congestive heart failure.
History of myocardial infarction within 1 year prior to Screening.
History of ulcerative colitis or Crohn's disease.
History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
History of a psychiatric disorder that would affect the subject's ability to participate in the study.
History of anaphylactic reaction(s) to any drug.
History of angioedema.
History of alcohol or substance abuse within the last 2 years.
History of any surgery that could potentially affect the absorption of the study drug.
Receipt of any investigational drug within the preceding 30 days or a history of receipt of an investigational antidiabetic drug within the preceding 90 days.