Phase 3 Alogliptin Pediatric Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin Benzoate; Placebo
Intervention description: Alogliptin benzoate tablets.; Alogliptin placebo-matching tablets.
Intervention MeSH terms: Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      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).
    

Eligibility criteria:

        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.