Intervention: Alogliptin
Trial phase: Phase 3
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: 213
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
Eligibility criteria:
Inclusion Criteria

Diagnosis of type 2 diabetes mellitus currently treated with metformin alone but, experiencing inadequate glycemic control. The participant should have received the metformin monotherapy for at least the 3 months prior to Screening; and must have a stable dose of greater than or equal to 1500 mg metformin for at least 8 weeks prior to randomization. Participants with a maximum tolerated dose that is documented to be less than 1500 mg of metformin may also be enrolled if this dose has been stable for 8 weeks prior to randomization.
No treatment with antidiabetic agents other than metformin within the 3 months prior to Screening. (Exception: if a participant has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the participant still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.
Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive
If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females
Alanine aminotransferase less than or equal to 3 time the upper limit of normal
Serum creatinine less than1.5 mg per dL for males and less than 1.4 mg per dL for females
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the participant is clinically euthyroid.
Neither pregnant nor lactating.
Female participants of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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
Able and willing to provide written informed consent Exclusion Criteria
Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the participant may be rescreened within 1 week.
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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening
History of treated diabetic gastric paresis
New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated participants who are stable at Class I or II are candidates for the study.
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 hepatitis B, hepatitis C, or 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
Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening
Prior treatment in an investigational study of alogliptin

Excluded Medications:

Treatment with antidiabetic agents other than study drug or metformin is not allowed within the 3 months prior to Screening and through the completion of the end-of treatment/early termination procedures.
Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed.
Participants must be instructed not to take any medications, including over-the-counter products, without first consulting with the investigator.