Evidence map›DPP-4 inhibitors × glycemic control›PMID 40302627›Full record

Trial reportDiabetes, obesity & metabolism2025

Fotagliptin add-on therapy to metformin in patients with uncontrolled type 2 diabetes: A randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.

Nan Yu, Wenjie Xu, Xiaohui Guo, Mingtong Xu, Wei Zhang, Chaoli Yan, Shuguang Pang, Xiuhai Shu, Wei Zhang, Weixia Peng and 4 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2025. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 2 papers.

1number the graph read from it
1cell 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.

← favours the treatmentfavours the comparator →
-0.680 · no effect
Change in HbA1c level from baseline to week 24fotagliptin vs placebofavours the treatment · t2dfeeds one cell of the map
Δ -0.53-0.68 to -0.39p < 0.001
Estimated treatment difference for fotagliptin versus placebo of HbA1c was -0.53% (95% confidence interval [CI] -0.68% to -0.39%; p < 0.001).
FeedsDPP-4 inhibitors×glycemic control

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

DPP-4 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 59 favour the treatment, 19 find no difference, 24 favour the comparator.

Belief with this paper
0.82replicated · 56 families support, 12 contradict · against placebo
Without it
0.82This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2025
Δ -0.53-0.68 to -0.39
NCT015282542,004 enrolled · 2012
Slope -0.02-0.05 to 0.00
NCT026078651,864 enrolled · 2016
Δ -0.50-0.60 to -0.40
NCT001216671,462 enrolled · 2005
Δ -0.73-0.92 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.27-0.48 to -0.05
NCT004827291,246 enrolled · 2007
Δ -0.60-0.78 to -0.43
NCT020991101,233 enrolled · 2014
Δ -0.46-0.63 to -0.30
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT022730501,136 enrolled · 2014
Δ -0.21-0.41 to -0.02
NCT004499301,050 enrolled · 2007
Δ 0.140.06 to 0.21
4 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

14 authors.

Nan YuPeking University First Hospital, Beijing, China.ORCID https://orcid.org/0009-0008-7162-2030
Wenjie XuShenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, China.
Xiaohui GuoPeking University First Hospital, Beijing, China.
Mingtong XuSun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Wei ZhangThe First Hospital of Qiqihar, Qiqihar, China.
Chaoli YanThe Affiliated Hospital of Inner Mongolia Medical University, Huhehaote, China.
Shuguang PangCerter Hospital Affiliated to Shandong First Medical University, Jinan, China.
Xiuhai ShuCangzhou Hospital of Integrated TCM-WM Heibei, Cangzhou, China.
Wei ZhangPuyang Oilfield General Hospital, Puyang, China.
Weixia PengYiyang Center Hospital, Yiyang, China.
Yawei ZhangPingxiang People's Hospital, Pingxiang, China.
Gaixian LiGeneral Hospital of Huabei Petroleum Administration Bureau, Cangzhou, China.
Xin ZhangGenertec Liaoyou Gem Flowe Hospital, Panjin, China.
Dongmei ZhouThe Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.

Funding

Shenzhen Salubris Pharmaceuticals Co., LtdShenzhen Salubris Pharmaceuticals Co.,LtdShenzhen Science and Technology Program for Undertake the National Science and Technology Major Project CJGJZD20210408091600001
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimFotagliptin is a novel dipeptidyl peptidase-4 inhibitor for glycaemic control in patients with type 2 diabetes (T2D). This trial aimed to assess the efficacy and safety of fotagliptin add-on to metformin in patients with T2D. MATERIALS AND

methodsIn this phase 3 randomised, double-blind, placebo-controlled study, patients with T2D who had inadequate glycaemic control using metformin alone were randomly allocated to fotagliptin or placebo at a 2:1 ratio for 24-week double-blind treatment period, followed by an open-label treatment with fotagliptin for all patients, making up a total of 52 weeks. All eligible patients were treated with a stable dose of metformin (≥1500 mg per day). The primary endpoint was the change in HbA1c level from baseline to week 24. Safety was assessed in all patients who received at least one dose of the study drug.

resultsAfter 24 weeks, LS mean change of HbA1c from baseline was -0.81% with fotagliptin versus -0.28% with placebo. Estimated treatment difference for fotagliptin versus placebo of HbA1c was -0.53% (95% confidence interval [CI] -0.68% to -0.39%; p < 0.001). Significantly more patients on fotagliptin than on placebo achieved HbA1c < 7.0% after 24 weeks (38.7% vs. 16.9%; p < 0.001). The incidence of adverse events was similar between the two groups. No severe hypoglycaemia events were reported in patients treated with fotagliptin and metformin combined therapy.

conclusionsIn patients with T2D who experienced inadequate glycaemic control with metformin, fotagliptin achieved a superior and clinically meaningful improvement in glycaemic control compared with placebo.

Indexed as

Diabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsHypoglycemic AgentsMetforminAdultAgedBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaMaleMiddle AgedTreatment OutcomeBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetformindipeptidyl peptidase‐4 inhibitorsfotagliptinHbA1cmetformintype 2 diabetes

Identifiers

PMID40302627
PMCPMC12146461

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.