Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

Inclusion criteria for children and adolescent participants only (Groups 1 and 2, respectively):

• Participant was male or female between 10 and 17 years of age.
• Participant or parent or legal guardian was capable of understanding and complying with the protocol requirements.
• Participant was capable of understanding an informed consent form (ICF) or assenting to participate. The parent or legal guardian of the participant must have been able to understand and sign an ICF prior to the initiation of any study procedures.
• Participant weighed at least 36 kg (79 pounds) and had a Screening body mass index (BMI) of at least 18 kg/m^2.
• Participants had a diagnosis of type 2 diabetes mellitus (T2DM) (non-insulin dependent) based on diagnostic criteria of the American Diabetes Association (ADA). Criteria included:
• Fasting plasma glucose level of ≥ 126 mg/dL where fasting is defined as no caloric intake for at least 8 hours, or
• 2-hour plasma glucose level of ≥ 200 mg/dL during an oral glucose tolerance test, or
• random plasma glucose level of ≥ 200 mg/dL, or
• glycated hemoglobin (HbA1c) ≥ 6.5%.
• Diagnosis could have been historical (documented), or participants could have been diagnosed for this study.
• Participants had a fasting serum C-peptide concentration ≥ 0.8 ng/mL (≥ 0.26 nmol/L) at the Screening Visit only.
• Participants may have been taking concomitant metformin if the dose was stable for at least 30 days prior to Day 1 (day of first dosing).

Inclusion criteria for adult participants only (Group 3):

• Participant was male or female, and between 18 and 65 years of age, inclusive for gender and race matched adult participants with T2DM only.
• Participant was capable of understanding and complying with protocol requirements and was willing to sign the ICF prior to the initiation of any study procedures for gender and race matched adult participants with T2DM only.
• Participant weighed at least 50 kg (110 pounds) and had a Screening BMI between 23 kg/m^2 and 45 kg/m^2 (except for Asian or Asian-descendant participants for whom the range was between 20 kg/m^2 and 35 kg/m^2), inclusive for gender and race matched T2DM adult participants only.
• Participants had a diagnosis of T2DM (non-insulin dependent) based on diagnostic criteria of the ADA. Criteria included:
• Fasting plasma glucose level of ≥ 126 mg/dL where fasting is defined as no caloric intake for at least 8 hours, or
• 2-hour plasma glucose level of ≥ 200 mg/dL during an oral glucose tolerance test, or
• random plasma glucose level of ≥ 200 mg/dL, or
• HbA1c ≥ 6.5%.
• Diagnosis could have been historical (documented) or participants could have been diagnosed for this study.
• Participants may have been taking concomitant metformin if the dose was stable for at least 30 days prior to Day 1.
• Participants may have been taking statin or antihypertensive drugs if the dose was stable for at least 30 days prior to Day 1.

Inclusion criteria for all participants (Groups 1, 2, and 3):

• Female participants of childbearing potential and male participants who were sexually active agreed to routinely use adequate contraception from Screening until 30 days after receiving the dose of study drug. NOTE: Women not of childbearing potential were defined as those who were surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation) or who were postmenopausal (defined as at least 45 years of age and 1 year since last regular menses).
• Participant had a negative urine test result for selected substances of abuse (including alcohol and cotinine) at Screening and Check-in (Day -1).
• Participant had clinical chemistry, hematology, and complete urinalysis (fasted for at least 8 hours) results within the reference range for the testing laboratory (except results associated with T2DM) unless the out-of-range results were deemed not clinically meaningful by the investigator or sponsor.
• Participant had a negative test r