Phase 3 Alogliptin Pediatric Study
Phase 3 Alogliptin Pediatric Study
The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg)
 once daily compared to placebo when administered as monotherapy, or when added onto a
 background of metformin alone, insulin alone, or a combination of metformin and insulin, as
 measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric
 participants with type 2 diabetes mellitus (T2DM).
The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat
 children 10 to 17 years of age who have T2DM and are experiencing inadequate glycemic
 control. This study will look at HbA1c fluctuations in children who take alogliptin in
 addition to their background antidiabetic therapy.

 The study will enroll approximately 150 participants. Participants will be randomly assigned
 (by chance, like flipping a coin) to one of the two treatment groups-which will remain
 undisclosed to the participant and study doctor during the study (unless there is an urgent
 medical need):

 -  Alogliptin 25 mg

 -  Placebo (dummy inactive pill) - this is a tablet that looks like the tablet containing
 alogliptin 25 mg but has no active ingredient (that is, has no alogliptin).

 All participants will be asked to take one tablet at the same time each day throughout the
 study in addition to their current background antidiabetic therapy (metformin and/or insulin)
 if applicable.

 This multi-center trial will be conducted in the United States, Brazil, Germany, Italy,
 Poland, Russia, Israel and Mexico. The overall time to participate in this study is
 approximately 56 weeks. Participants will make multiple visits to the clinic, and will be
 contacted by telephone 2 weeks after the last dose of study drug for a follow-up assessment.
Inclusion Criteria:

 1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World
 Health Organization (WHO) criteria (laboratory determinations of fasting plasma
 glucose [FPG] greater than or equal to [>=] 126 mg/dL, random glucose >=200 mg/dL
 [>=11.10 mmol/L], HbA1c >=6.5 percent (%), or 2-hour oral glucose tolerance test
 [OGTT] glucose >=200 mg/dL), documented in the participants' medical record.

 2. The participant and/or his/her legal representative (that is, parents or legal
 guardians) are able and willing to monitor their own blood glucose concentrations with
 a home glucose monitor and complete participant diaries.

 Exclusion Criteria:

 1. Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl
 peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.

 2. Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of
 the young (MODY).

 3. Has a hemoglobin level <11.0 gram per deciliter (g/dL) (<110 gram per liter [g/L]) for
 males and <10.0 g/dL (<100 g/L) for females.

 4. Has a history of any hemoglobinopathy that may affect determination of HbA1c levels.

 5. Has a history of bariatric surgery.

 6. Has a history of proliferative diabetic retinopathy within the 6 months prior to
 Screening.

 7. Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis
 of T2DM.

 8. Has a history of more than 1 episode of pancreatitis.

 9. Has serum creatinine >=1.5 mg/dL for male participants or >=1.4 mg/dL for female
 participants, or creatinine clearance <60 milliliter per minute (mL/min) based on
 calculation by central lab using the Schwartz formula for estimated glomerular
 filtration rate (eGFR) at screening Visit.

 10. Has a documented history of infection with human immunodeficiency virus or chronic
 active viral hepatitis.

 11. The participant and/or his/her legal representative (that is, parents or legal
 guardians) is unable to understand verbal or written English, or any other language
 for which a certified translation of the approved informed consent/assent is
 available.

 Additional Criteria That Must be Met Prior to Randomization:

 For participants who have had the diagnosis of T2DM for less than 1 year and/or who are
 taking insulin at Screening, additional criteria will need to be met prior to
 randomization:

 1. Must have an HbA1c level of >=6.5% to <11.0% if the participant is treatment naïve or
 on metformin alone or >=7.0% to <11.0% if the participant is on insulin alone or in
 combination with metformin.

 2. The participant must not have received any investigational compound within 30 days or
 5 half-lives, whichever is longer, prior to randomization.

 3. Must not have received an antidiabetic agent other than metformin or insulin within
 the 12 weeks prior to randomization.

 4. Must not have received oral or parenteral steroids for more than 3 weeks
 (cumulatively) within the 6 months prior to randomization or have received a course of
 oral or parenteral steroids within the 2 months prior to randomization.

 5. Has a systolic blood pressure <160 millimeter of mercury (mmHg) and a diastolic
 pressure <100 mm Hg. (Antihypertensive medications will be allowed during the study).

 6. Has an alanine aminotransferase (ALT) level <3*upper limit of normal (ULN) or an ALT
 level <5 *ULN with a confirmed diagnosis of nonalcoholic fatty liver disease
 (NAFLD).7. Does not plan to leave the geographic area within 1 calendar year following
 randomization.

 For participants who have had the diagnosis of T2DM for less than 1 year and/or who are
 taking insulin prior to randomization, the following criteria must also be met:

 8. Must have a fasting C-peptide concentration>=0.6 nanogram per milliliter (ng/mL) (>=0.20
 nanomole per liter [nmol/L]) (drawn at least 1 week after treatment for ketosis or
 acidosis, if applicable).

 9. No presence of autoantibodies as documented by glutamic acid decarboxylase [GAD] 65 and
 islet antigen [IA]-2 antibodies below the upper limit of the normal reference ranges at
 randomization.

 10. Have a body mass index (BMI) greater than (>) 85th percentile, documented at
 randomization.