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Research Summary
Analyzed using Evidence Intelligence™

Alogliptin shows no significant improvement in glycemic control for pediatric T2DM

Powered by the Dediabetes Evidence Intelligence™ framework

Last updated September 9, 2026

Key finding

The difference in HbA1c levels from baseline to week 26 between the alogliptin and placebo groups was 0.10 (−0.63, 0.83; p = 0.78).

This Phase 3 trial evaluated the efficacy and safety of alogliptin in pediatric patients with type 2 diabetes mellitus, finding no significant difference in HbA1c levels compared to placebo.

Quick read

Study at a glance

The essential study design details in one scan.

EvidenceScore™

Moderate

Study type

RCTs

Follow-up

Long-Term (1–5 y)

Risk of bias

Some Concerns

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Plain-language summary

What this paper says

A plain-language read of the study’s main message and where it applies.

Study focus

This Phase 3 trial evaluated the efficacy and safety of alogliptin in pediatric patients with type 2 diabetes mellitus, finding no significant difference in HbA1c levels compared to placebo.

Clinical relevance

Understanding the efficacy and safety of diabetes medications in children is crucial for developing appropriate treatment plans. This study suggests that alogliptin may not provide additional benefits in controlling blood sugar levels in pediatric patients, highlighting the need for further research into effective treatments for this population.

Keep in mind

The study may have limited generalizability due to its specific population. Effectiveness findings were unclear due to the small difference in HbA1c. The trial duration may not be sufficient to assess long-term effects.

Published in

Journal Reference

Publication details and source links for this paper.

Xuejun VP, Georgeanna K, Daniel SH, et al. Efficacy and Safety of Alogliptin in Pediatric Patients with Type 2 Diabetes Mellitus: A Phase 3 Trial. Diabetes Therapy. 2025;16(5):865-883. doi:10.1007/s13300-025-01700-3

View DOIView on PubMedView on PMC

Main Effects

No significant difference in HbA1c levels between alogliptin and placebo (0.10%, p = 0.78).

No new safety concerns observed with alogliptin treatment.

Evidence network

How this study fits

Understand where this research contributes within the broader evidence network.

Evidence Context

This study contributes evidence to Alogliptin 25 mg QD and HbA1c, Safety profile assessment.

This study contributes evidence to

Intervention

Alogliptin 25 mg QD

Outcome

HbA1c

Evidence topic

HbA1c Reduction

Primary intervention

Alogliptin 25 mg QD

Primary outcomes

  • HbA1c
  • Safety profile assessment

Evidence topics

HbA1c Reduction

Primary intervention

Alogliptin 25 mg QD

Primary outcomes

HbA1cSafety profile assessment

Evidence relationships

Intervention and outcome relationships this study adds to the evidence network.

2
Evidence pairs
2
Relationships
1
Evidence topics
contributes_evidence

Editorial context

Why this study matters

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Evidence network role

This section describes how the study fits into the current evidence network. It does not determine whether an intervention works on its own.

Moderate contributionModerate confidenceNetwork score: 55

1

Related topics

2

Evidence pairs

544

Related studies

High relevance in at least one topic

Why it is useful

  • Contributes to 2 evidence relationships
  • Includes primary outcome data
  • Linked to 1 direct semantic evidence topic

Topic contributions

Evidence topic

Contributes evidence

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Primary evidence

Evidence topic

HbA1c Reduction

matched_outcome

Core evidence

Study findings

The primary outcomes reported in this study.

HbA1c

Alogliptin 25 mg QD → HbA1c

Alogliptin 25 mg QD → HbA1c

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
50
Neutral
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

Safety profile assessment

Alogliptin 25 mg QD → Safety profile assessment

Alogliptin 25 mg QD → Safety profile assessment

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
50
Neutral
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

Evidence Library

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evidence suggest

Evidence Suggest

  • Alogliptin showed no significant change in HbA1c levels (0.10%, p = 0.78).
  • Safety assessments revealed no new concerns with alogliptin.
who this applies

Who this applies to

  • Pediatric patients diagnosed with type 2 diabetes mellitus.
  • Participants aged 10-17 years.
keep in mind

Keep in Mind

  • Findings may not apply to all pediatric populations with diabetes.
  • The study's short duration limits long-term efficacy conclusions.
  • Further research is needed to explore alternative treatments.
between the lines

Between the Lines

  • The study may have limited generalizability due to its specific population.
  • Effectiveness findings were unclear due to the small difference in HbA1c.
  • The trial duration may not be sufficient to assess long-term effects.

Evidence Library

Build your evidence library

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Connected Evidence

Explore related studies, evidence collections, and research questions.

Relationships organized using the Dediabetes Evidence Intelligence™ framework.

Powered by the Dediabetes Evidence Intelligence™ framework

This study contributes to evidence on Alogliptin 25 mg QD and HbA1c, Alogliptin 25 mg QD and Safety profile assessment.

Related evidence relationships

Explore in Evidence Explorer

This study contributes to the evidence on the following intervention-outcome relationships.

Questions answered by this study

Generated from the study's connected evidence using Evidence Intelligence™.

Does Alogliptin 25 mg QD lower HbA1c?

Emerging Evidence

Current evidence does not show a clear benefit of Alogliptin 25 mg QD for HbA1c.

ConsistencyScore™: Consistency cannot yet be determined from the available evidence.

Ranked evidence signals

  1. 1

    HbA1c

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on a single supporting study.

Limitations

  • Only one supporting study is available.
1 supporting study
View Full Evidence

Does Alogliptin 25 mg QD affect safety profile assessment?

Emerging Evidence

Current evidence does not show a clear effect of Alogliptin 25 mg QD on safety profile assessment.

ConsistencyScore™: Consistency cannot yet be determined from the available evidence.

Ranked evidence signals

  1. 1

    Safety profile assessment

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on a single supporting study.

Limitations

  • Only one supporting study is available.
1 supporting study
View Full Evidence
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Next steps

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Evidence topics

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HbA1c Reduction Evidence Hub

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All studies on Alogliptin 25 mg QD and HbA1cAll studies on Alogliptin 25 mg QD and Safety profile assessment

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Read related research summaries.

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