Evidence map›Paper›PMID 40032809›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2025

A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus.

Xuejun Victor Peng, Georgeanna Klingensmith, Daniel S Hsia, Yunlong Xie, Richard Czerniak, William V Tamborlane, Amy S Shah

Registry-linked trialAbstract read
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In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02856113 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02856113 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus

TypeinterventionalSponsorTakedaRan2016 to 2022Enrolled152ConditionsDiabetes Mellitus, Type 2ArmsAlogliptin Benzoate, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Xuejun Victor PengMarketed Products Development, Global Portfolio Division, Takeda Pharmaceuticals Company Limited, Cambridge, MA, USA.
Georgeanna KlingensmithBarbara Davis Center, Department of Pediatrics, University of Colorado, Aurora, CO, USA.
Daniel S HsiaPennington Biomedical Research Center, Baton Rouge, LA, USA.
Yunlong XieStatistics and Quantitative Science, Takeda Pharmaceuticals Company Limited, Cambridge, MA, USA.
Richard CzerniakQuantitative Clinical Pharmacology, Takeda Pharmaceuticals Company Limited, Cambridge, MA, USA.
William V TamborlaneDepartment of Pediatrics and General Clinical Research Center, Yale University School of Medicine, New Haven, CT, USA.
Amy S ShahDivision of Pediatric Endocrinology, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, 3333 Burnet Ave, ML 7012, Cincinnati, OH, 45229, USA. amy.shah@cchmc.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is an unmet need for pharmacological therapies for children with type 2 diabetes mellitus (T2DM). We assessed the efficacy and safety of an oral dipeptidyl peptidase-4 inhibitor, alogliptin, 25 mg once daily (QD), as a potential treatment for pediatric patients with T2DM.

methodsThis phase 3, 52-week, multicenter, randomized, double-blind, placebo-controlled trial was conducted in children and adolescents (10-17 years old) with T2DM. Participants had glycosylated hemoglobin (HbA1c) ≥ 6.5% at baseline (≥ 6.5% to < 11% without treatment or on metformin alone; ≥ 7.0% to < 11% on insulin alone or in combination with metformin). Where required, participants underwent prerandomization stabilization of their background metformin and/or insulin therapy. All received diabetes education and home glucose-monitoring training (during screening, prerandomization stabilization, and specified visits through week 26). Participants were then stratified based on previous antihyperglycemic therapy for 12 weeks before screening into schedule A (antihyperglycemic treatment-naïve) or B (metformin and/or insulin). The primary efficacy endpoint was change in HbA1c levels from baseline at week 26. Safety was assessed as a secondary endpoint at week 52.

resultsOverall, 152 participants (median age, 14 years; 68.9% female) were randomized (1:1) to receive either alogliptin (n = 75) or placebo (n = 77). The majority were white (58.3%), had a body mass index of ≥ 30 kg/m

conclusionAlogliptin 25 mg QD did not significantly improve glycemic control versus placebo in pediatric patients with T2DM. Alogliptin treatment was safe and well tolerated, and no new safety concerns were observed in this study.

trial registrationClinicalTrials.gov: NCT02856113; EudraCT: 2015-000208-25.

Indexed as

AlogliptinAntihyperglycemic agentsDipeptidyl peptidase-4 inhibitorDPP-4 inhibitorPediatric type 2 diabetes mellitusYouth-onset type 2 diabetes mellitus

Identifiers

PMID40032809
PMCPMC12006607

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.