Última actualización 18 de julio de 2026
Key finding
HbA1c decreased by 0.65% from baseline.
This study evaluated the efficacy and safety of imeglimin as an add-on therapy to DPP-4 inhibitors in patients with type 2 diabetes, showing mixed results in glycemic control.
Quick read
The essential study design details in one scan.
EvidenceScore™
Moderate
Study type
RCTs
Follow-up
Medium-Term (3–12 mo)
Risk of bias
Some Concerns
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Plain-language summary
A plain-language read of the study’s main message and where it applies.
Study focus
This study evaluated the efficacy and safety of imeglimin as an add-on therapy to DPP-4 inhibitors in patients with type 2 diabetes, showing mixed results in glycemic control.
These findings are significant for clinicians treating type 2 diabetes, as they highlight the potential of imeglimin to enhance glycemic control when used with DPP-4 inhibitors. Understanding the efficacy and safety of new treatment options is crucial for optimizing diabetes management and improving patient outcomes.
The study did not assess long-term effects beyond the trial period. Sample size and demographic diversity were not specified. Some outcomes showed increases in the placebo group, complicating interpretation.
Published in
Publication details and source links for this paper.
Kohei K, Masashi S, Takeshi O, Masahiro I, Hideaki K. Efficacy and safety of imeglimin add-on therapy to DPP-4 Inhibitor in patients with type 2 diabetes mellitus: A Randomized, double-blind, clinical trial. Diabetes, Obesity & Metabolism. 2025;27(6):3212-3222. doi:10.1111/dom.16336
HbA1c decreased by 0.65% in the imeglimin group (p=0.001)
Fasting plasma glucose decreased by 16.9 mg/dL in the imeglimin group (p=0.001)
Serum insulin increased by 9.55 µIU·h/mL in the imeglimin group (p=0.015)
Evidence network
Understand where this research contributes within the broader evidence network.
This study contributes evidence to Imeglimin and Change in glycoalbumin from baseline, Fasting Plasma Glucose (FPG), Fasting insulin levels, and 1 more.
This study contributes evidence to
Primary intervention
Imeglimin
Primary outcomes
Evidence topics
Primary intervention
Intervention and outcome relationships this study adds to the evidence network.
Editorial context
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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.
3
Related topics
4
Evidence pairs
1489
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Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
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Evidencia principal
Tema de evidencia
matched_outcome
Evidencia relacionada
Tema de evidencia
Guardar evidencia
Core evidence
The primary outcomes reported in this study.
Imeglimin → Change in glycoalbumin from baseline
Imeglimin → Change in glycoalbumin from baseline
Imeglimin → Fasting Plasma Glucose (FPG)
Imeglimin → Fasting Plasma Glucose (FPG)
Evidence Library
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Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on Imeglimin and HbA1c, Imeglimin and Change in glycoalbumin from baseline.
This study contributes to the evidence on the following intervention-outcome relationships.
Medications
Curated evidence collections and hubs this study is part of.
All studies measuring HbA1c
Measures HbA1c as a key outcome.
All studies on Imeglimin
Contributes to Imeglimin evidence base.
All studies measuring Change in glycoalbumin from baseline
Measures Change in glycoalbumin from baseline as a key outcome.
Latest published studies
Published within the last 2 years.
Jump to pre-filtered views in Evidence Explorer.
4 results
2 results
4 results
4 results
2 results
Generated from the study's connected evidence using Evidence Intelligence™.
Imeglimin appears to lower HbA1c.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
HbA1c
EvidenceScore™ Strong | EvidenceScore™ 79.0 | strong positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Imeglimin appears to improve change in glycoalbumin from baseline.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
Change in glycoalbumin from baseline
EvidenceScore™ Moderate | EvidenceScore™ 69.0 | strong positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Imeglimin appears to improve fasting plasma glucose (FPG).
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Fasting Plasma Glucose (FPG)
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | strong positive | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Imeglimin may worsen fasting insulin levels or be associated with harm.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Fasting insulin levels
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | moderate negative | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
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