Last updated August 16, 2026
Key finding
LS mean change of HbA1c from baseline was -0.81% with fotagliptin.
This study evaluated the efficacy and safety of fotagliptin as an add-on therapy for patients with uncontrolled type 2 diabetes, finding significant improvements in HbA1c levels compared to placebo.
Quick read
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
A plain-language read of the study’s main message and where it applies.
Study focus
This study evaluated the efficacy and safety of fotagliptin as an add-on therapy for patients with uncontrolled type 2 diabetes, finding significant improvements in HbA1c levels compared to placebo.
Effective management of blood sugar levels is crucial for patients with type 2 diabetes to prevent complications. The significant improvement in HbA1c with fotagliptin suggests it may be a valuable option for patients who struggle to achieve glycemic control with their current treatment. This finding supports the need for additional therapies in managing diabetes effectively.
The study did not report statistically significant changes in fasting plasma glucose. Body weight changes were not reported as statistically significant. The generalizability of findings may be limited to the specific population studied.
Published in
Publication details and source links for this paper.
Nan Y, Wenjie X, Xiaohui G, et al. Efficacy and safety of fotagliptin add-on therapy in patients with uncontrolled type 2 diabetes. Diabetes, Obesity & Metabolism. 2025;27(7):3933-3942. doi:10.1111/dom.16427
Fotagliptin reduced HbA1c by -0.81% compared to -0.28% with placebo (p < 0.001).
38.7% of patients on fotagliptin achieved HbA1c < 7.0% versus 16.9% on placebo (p < 0.001).
The incidence of adverse events was similar between fotagliptin and placebo groups.
Evidence network
Understand where this research contributes within the broader evidence network.
This study contributes evidence to Dipeptidyl peptidase-4 inhibitors and Fasting Plasma Glucose (FPG), Gastrointestinal disorders incidence, HbA1c, and 1 more.
This study contributes evidence to
Primary intervention
Dipeptidyl peptidase-4 inhibitors
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
642
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Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
Evidence topic
Contributes evidence
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Primary evidence
Evidence relationship
Related evidence
Evidence relationship
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Evidence relationship
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Core evidence
The primary outcomes reported in this study.
Dipeptidyl peptidase-4 inhibitors → Fasting Plasma Glucose (FPG)
Dipeptidyl peptidase-4 inhibitors → Fasting Plasma Glucose (FPG)
Dipeptidyl peptidase-4 inhibitors → Gastrointestinal disorders incidence
Dipeptidyl peptidase-4 inhibitors → Gastrointestinal disorders incidence
Dipeptidyl peptidase-4 inhibitors → Proportion achieving HbA1c <7.0%
Dipeptidyl peptidase-4 inhibitors → Proportion achieving HbA1c <7.0%
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Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on DPP-4 Inhibitors and HbA1c, DPP-4 Inhibitors and Fasting Glucose.
This study contributes to the evidence on the following intervention-outcome relationships.
Medications
Medications
Curated evidence collections and hubs this study is part of.
All studies on DPP-4 Inhibitors
Contributes to DPP-4 Inhibitors evidence base.
All studies measuring HbA1c
Measures HbA1c as a key outcome.
All studies measuring Fasting Glucose
Measures Fasting Glucose as a key outcome.
Latest published studies
Published within the last 2 years.
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5 results
3 results
5 results
5 results
3 results
Generated from the study's connected evidence using Evidence Intelligence™.
DPP-4 Inhibitors appears to improve HbA1c.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
HbA1c
EvidenceScore™ Strong | EvidenceScore™ 85.0 | strong positive | ConsistencyScore™ Consistent | 1 study
Proportion achieving HbA1c <7.0%
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | strong positive | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on 11 supporting studies with consistent results and a positive effect signal.
Limitations
DPP-4 Inhibitors may improve Fasting Glucose.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
Fasting Plasma Glucose (FPG)
EvidenceScore™ Strong | EvidenceScore™ 79.0 | moderate positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 6 supporting studies with consistent results and a positive effect signal.
Limitations
Current evidence does not show a clear benefit of DPP-4 Inhibitors for Gastrointestinal Adverse Events.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Gastrointestinal disorders incidence
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
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