Evidence map›Paper›PMID 28075066›Full record

Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of fixed-dose combination therapy, alogliptin plus metformin, in Asian patients with type 2 diabetes: A phase 3 trial.

Linong Ji, Ling Li, Jian Kuang, Tao Yang, Dong-Jun Kim, Azidah A Kadir, Chien-Ning Huang, Douglas Lee

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 11% of its field
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.

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

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Metformin for the Treatment of Type 2 Diabetes in Asian Adults: A Systematic Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Review
  10. Genome-Wide Transcriptome Analysis in Type 2 Diabetes Patients Treated by Sitagliptin.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022
    Article
  11. Review
  12. Article
  13. Review
  14. Efficacy and Safety of Initial Combination Therapy in Treatment-Naïve Type 2 Diabetes Patients: A Systematic Review and Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Article
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

8 authors at 8 institutions in 5 countries.

Linong JiDepartment of Endocrinology, Peking University People's Hospital, Beijing, China.ORCID 0000-0003-1305-1598
Ling LiDepartment of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, China.
Jian KuangDepartment of Endocrinology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Tao YangDepartment of Endocrinology, Jiangsu Province Hospital, Nanjing, China.
Dong-Jun KimDepartment of Internal Medicine, Ilsan Paik Hospital, Inje University, Goyang, Korea.
Azidah A KadirDepartment of Family Medicine, Universiti Sains Malaysia, Kubang Kerian, Malaysia.
Chien-Ning HuangDepartment of Endocrinology and Metabolism, Chung Shang Medical University Hospital, Taichung City, Taiwan, China.
Douglas LeeTakeda Development Centre Europe, Ltd, London, United Kingdom.
China Medical University · CNChung Shan Medical University Hospital · TWGuangdong General Hospital · CNInje University Ilsan Paik Hospital · KRJiangsu Province Hospital · CNPeking University · CNTakeda (United Kingdom) · GBUniversiti Sains Malaysia · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin A1c (HbA1c) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26). In total, 647 patients were randomized. The least-squares mean change in HbA1c from baseline to Week 26 was -0.19% with placebo, -0.86% with alogliptin, -1.04% with metformin and -1.53% with alogliptin + metformin FDC. Alogliptin + metformin FDC was significantly more effective ( P  < .0001) in lowering HbA1c than either alogliptin or metformin alone. The safety profile of alogliptin + metformin FDC was similar to that of the individual components alogliptin and metformin. The study demonstrated that treatment with alogliptin + metformin FDC BID resulted in better glycaemic control than either monotherapy and was well tolerated in Asian patients with type 2 diabetes.

Indexed as

ChinaCombined Modality TherapyDiabetes Mellitus, Type 2Diet, DiabeticDipeptidyl-Peptidase IV InhibitorsDrug Therapy, CombinationExerciseGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsImmunity, MucosalIncidenceMalaysiaMetforminalogliptinDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminPiperidinesUracilalogliptinDPP-IV inhibitorglycaemic controlmetformintype 2 diabetes

Identifiers

PMID28075066
PMCPMC5412676
OpenAlexW2574465100

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.