Evidence map›Paper›PMID 33855222›Full record

Trial reportEndocrinology, diabetes & metabolism2021

Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study.

Linong Ji, Ling Li, Jianhua Ma, Xuefeng Li, Dongmei Li, Bangzhu Meng, Weiping Lu, Jiao Sun, Yanmei Liu, Gen Takayanagi and 1 more

Open access · goldFull text readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Endocrinology, diabetes & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Metformin for the Treatment of Type 2 Diabetes in Asian Adults: A Systematic Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Review
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

11 authors at 9 institutions in 2 countries.

Linong JiPeking University People's Hospital, Beijing, China.ORCID https://orcid.org/0000-0003-1305-1598
Ling LiShengjing Hospital of China Medical University, Liaoning, China.
Jianhua MaNanjing First Hospital, Nanjing, Jiangsu, China.
Xuefeng LiShiyan Taihe Hospital, Hubei, China.
Dongmei LiInner Mongolia People's Hospital, Inner Mongolia, China.
Bangzhu MengThe Affiliated Hospital of Inner Mongolia University for Nationalities, Inner Mongolia, China.
Weiping LuHuai'an First People's Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Jiao SunHuadong Hospital Affiliated to Fudan University, Shanghai, China.
Yanmei LiuYancheng City No.1 People's Hospital, Jiangsu, China.
Gen TakayanagiMitsubishi Tanabe Pharma Development America, Inc., Jersey City, NJ, USA.
Yi WangMitsubishi Tanabe Pharma Development (Beijing) Co., Ltd., Beijing, China.ORCID https://orcid.org/0000-0001-6280-6593
China Medical University · CNFudan University · CNHuaian First People’s Hospital · CNInner Mongolia People's Hospital · CNInner Mongolia University for Nationalities · CNMitsubishi Corporation (United States) · USNantong University · CNPeking University · CNTaihe Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: We evaluated the efficacy and safety of teneligliptin compared with placebo when added to metformin therapy in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy. Methods: This multicentre, randomized, double-blind, placebo-controlled, parallel-group study enrolled type 2 diabetes patients with glycosylated haemoglobin (HbA1c) 7.0%-<10.0% and fasting plasma glucose (FPG) <270 mg/dl, receiving a stable metformin dose ≥1000 mg/day. Teneligliptin 20 mg or placebo was administered orally once daily (qd) before breakfast for 24 weeks. The primary efficacy end-point was change in HbA1c from baseline to Week 24. Safety end-points included the incidence of adverse events (AEs). Results: The least square mean (LSM) change from baseline (standard error [SE]) was -0.72 (0.07) (95% confidence intervals [CI], -0.87, -0.58) for teneligliptin and -0.01 (0.07) (95% CI, -0.16, 0.13) for placebo. The differences (LSM ± SE) between the placebo and teneligliptin groups in HbA1c and FPG were -0.71% ± 0.11% ( Conclusions: Teneligliptin 20 mg qd for 24 weeks added to ongoing metformin treatment significantly decreased HbA1c and FPG levels compared with placebo in Chinese type 2 diabetes patients. The combination was safe and tolerable.

Indexed as

Asian PeopleBiomarkersBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFastingGlycated HemoglobinGlycemic ControlHumansMetforminPlacebosPyrazolesSafetyThiazolidinesTreatment Outcome3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidineBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanMetforminPlacebosPyrazolesThiazolidinesdiabetes mellitusdipeptidyl peptidase‐IV inhibitorsmetformintype 2

Identifiers

PMID33855222
PMCPMC8029565
OpenAlexW3124847857

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Registered trials

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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 OpenQuestion graph.