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 worldwide. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
Alogliptin benzoate tablets.
Alogliptin placebo-matching tablets.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.
Time frame: Baseline and Week 26
Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Weeks 12, 18, 39 and 52 relative to Baseline. MMRM was used for the analysis.
Time frame: Baseline and Weeks 12, 18, 39 and 52
Percentage of Participants With Clinically Significant Physical Examination Findings
Physical examination included examination of the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. A summarized data for the above body systems was reported for participants with clinically significant findings.
Time frame: From Day 1 to end of treatment period (up to 52 weeks)
Percentage of Participants With Abnormal Vital Signs Values
Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure \[systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] resting more than 5 minutes, and pulse (beats per minute). Data for participants with abnormal vital signs was reported. The percentage of participants are calculated based on the participants with non-missing data at that time-point.
Time frame: From Day 1 to end of treatment period (up to 52 weeks)
Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
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Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Sherif Khamis
Palmdale, California, United States
Lucile Packard Children's Hospital at Stanford University
Palo Alto, California, United States
Touro University California
Vallejo, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Children's National Health System
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Nemours Childrens Specialty Care - Jacksonville
Jacksonville, Florida, United States
Baptist Diabetes Associates Research
Miami, Florida, United States
...and 57 more locations
Time frame: Week 26 and 52
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time frame: From the study start up to end of the study (up to 54 weeks)
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
The percentage of participants are calculated based on the participants with non-missing data at that time-point.
Time frame: From Day 1 to end of treatment period (up to 52 weeks)
Percentage of Participants With Hypoglycemia
Mild to moderate hypoglycemia (abnormal low blood sugar) was defined as blood glucose less than (\<) 60 milligram per deciliter (mg/dL) (3.33 millimole per liter \[mmol/L\]) in the presence of symptoms, or blood glucose \<50 mg/dL (2.78 mmol/L) with or without symptoms. Severe hypoglycemia was defined as any episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, associated with a documented blood glucose \<60 mg/dL (3.33 mmol/L) (unless the clinical situation makes obtaining a blood glucose difficult \[example, it involves coma or seizure\]).
Time frame: From Day 1 to end of treatment period (up to 52 weeks)
Percentage of Participants With Abnormal Safety Laboratory Findings
The percentage of participants with any abnormal standard safety laboratory values (hematology, serum chemistry, and urinalysis) were collected throughout study. Abnormal values for hematology included hematocrit (percentage of hematocrit \[%\]), hemoglobin (grams per liter \[g/L\]), erythrocyte mean corpuscular volume (MCV)(femtoliter \[fL\]), erythrocytes (10\^12/L), and leukocytes (10\^9/L). Abnormal values for serum chemistry included for alanine aminotransferase (units per liter \[U/L\]), aspartate aminotransferase (U/L), cholesterol (millimoles per liter \[mmol/L\]), gamma glutamyl transferase (U/L), glucose (mmol/L): \< 2.8 mmol/L, potassium (mmol/L), sodium (mmol/L), and triglycerides (mmol/L). ULN is upper limit of normal and LLN is lower limit of normal.
Time frame: From Day 1 to end of treatment period (up to 52 weeks)
Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52
Biomarkers of bone turnover are bone-specific alkaline phosphatase to assess changes in bone formation and C-terminal telopeptide (CTX) to assess changes in bone resorption.
Time frame: Baseline, Weeks 26 and 52
Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52
Time frame: Baseline, Weeks 26 and 52
Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52
Time frame: Baseline, Weeks 26 and 52