Phase 3
Completed N=152
Phase 3 Alogliptin Pediatric Study
Diabetes Mellitus, Type 2
Source: ClinicalTrials.gov NCT02856113 ↗
Enrolled (actual)
152
Serious AEs
3.3%
Results posted
Oct 2022
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 — -0.011; 0.091 percentage of HbA1c — p==0.782
◆ Published Evidence
Emerging
2citations · ~2 / year
A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus.
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).
Linked Publications
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A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 |
-0.011; 0.091 | =0.782 |
| SECONDARY Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52 |
-0.319; -0.365; -0.206; -0.202; 0.502; 0.091 | =0.863 |
| SECONDARY Percentage of Participants With Clinically Significant Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Abnormal Vital Signs Values |
1.3; 2.8; 4.0; 4.2; 1.4; 1.4 | — |
| SECONDARY Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings |
7; 6; 2; 0; 7; 6 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAE) |
76.3; 80.0 | — |
| SECONDARY Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions |
0.0; 11.1; 9.1; 0.0; 0.0; 11.1 | — |
| SECONDARY Percentage of Participants With Hypoglycemia |
7.9; 5.3 | — |
| SECONDARY Percentage of Participants With Abnormal Safety Laboratory Findings |
10.7; 5.6; 2.7; 1.3; 1.4; 2.7 | — |
| SECONDARY Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52 |
62.09; 62.62; -6.20; -7.47; -14.36; -15.43 | — |
| SECONDARY Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52 |
78.2; 77.7; 1.2; 1.6; 1.0; 0.8 | — |
| SECONDARY Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52 |
59.7; 59.6; -0.2; 1.7; 1.0; -0.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
- Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.
- Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY).
- Has a hemoglobin level =1.5 mg/dL for male participants or >=1.4 mg/dL for female participants, or creatinine clearance =6.5% to =7.0% to =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).
- 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.
- Have a body mass index (BMI) greater than (>) 85th percentile, documented at randomization.
Data sourced from ClinicalTrials.gov (NCT02856113) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.