Last updated on June 2019

Phase 3 Alogliptin Pediatric Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM
  • Age: Between 10 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Has a confirmed diagnosis of type 2 diabetes mellitus (T2DM) using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose (FPG) 126 mg/dL, random glucose 200 mg/dL [11.10 mmol/L], glycosylated hemoglobin (HbA1c) 6.5%, or 2-hour oral glucose tolerance test [OGTT] glucose 200 mg/dL), documented in the participants' medical record.
  2. Documented fasting C-peptide concentration 0.6 ng/mL (0.20 nmol/L) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable).
  3. Documented glutamic acid decarboxylase [GAD] 65 and islet cell antigen [ICA] 512 antibodies below the upper limit of the normal reference ranges.
  4. Has body mass index (BMI) 85th percentile, documented at Screening.
  5. Is thought to be able to swallow the tablet containing the study medication.
  6. The participant and/or his/her legal representative (ie, 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 g/dL (<110 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 mL/min based on calculation by central lab using the Cockcroft-Gault approximation 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 (ie, 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:

  1. Must have an HbA1c level of 6.5% to <11.0%.
  2. Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization.
  3. 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.
  4. Has a systolic blood pressure <160 mmHg and a diastolic pressure <100 mmHg. (Antihypertensive medications will be allowed during the study).
  5. 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).
  6. Does not plan to leave the geographic area within 1 calendar year following randomization.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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