Evidence map›Paper›PMID 27181998›Full record

Trial reportJournal of diabetes investigation2016

Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus.

Linong Ji, Ping Han, Xiaoyue Wang, Jingdong Liu, Shaoxiong Zheng, Ying-Ming Jou, Edward A O'Neill, Gregory T Golm, Samuel S Engel, Keith D Kaufman and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01076088. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
2.5field-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.

NCT01076088 phase3completed

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

Ran2010Enrolled744Registered outcomes3Posted comparisons36ConditionsType 2 Diabetes MellitusArmsMetformin 500 mg, Metformin 850 mg, Placebo, Sitagliptin 100 mg, Sitagliptin 50 mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Review
  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. Article
  11. Review
  12. Association ofBiomedicines · 2022
    Article
  13. Review
  14. Genome-Wide Transcriptome Analysis in Type 2 Diabetes Patients Treated by Sitagliptin.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022
    Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. 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

11 authors at 6 institutions in 2 countries.

Linong JiPeking University People's Hospital, Beijing, China.
Ping HanShengjing Hospital, China Medical University, Shenyang, China.
Xiaoyue WangThe First People's Hospital of Yueyang, Yueyang, China.
Jingdong LiuJiangxi Province People's Hospital, Nanchang, China.
Shaoxiong ZhengThe Second Hospital of Tianjin Medical University, Tianjin, China.
Ying-Ming JouMerck & Co., Inc, Kenilworth, New Jersey, USA.
Edward A O'NeillMerck & Co., Inc, Kenilworth, New Jersey, USA.
Gregory T GolmMerck & Co., Inc, Kenilworth, New Jersey, USA.
Samuel S EngelMerck & Co., Inc, Kenilworth, New Jersey, USA.
Keith D KaufmanMerck & Co., Inc, Kenilworth, New Jersey, USA.
R Ravi ShankarMerck & Co., Inc, Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USChina Medical University · CNJiangxi Provincial People's Hospital · CNPeking University · CNSecond Hospital of Tianjin Medical University · CNYueyang Second People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe results of a clinical trial to evaluate the efficacy and safety of initial combination therapy with sitagliptin and metformin in Chinese patients with type 2 diabetes and inadequate glycemic control are reported here. MATERIALS AND

methodsThis was a multicenter, randomized, double-blind, placebo-controlled, parallel group, 24-week clinical trial carried out in China. Patients (n = 744) with type 2 diabetes and inadequate glycemic control (glycated hemoglobin ≥7.5 and ≤11.0%) who were either drug-naïve or washed out of previous therapy were randomized in equal ratios to sitagliptin 100 mg once daily (q.d.; S100), metformin 500 mg twice daily (b.i.d.; M1000), metformin 850 mg b.i.d. (M1700), sitagliptin 50 mg b.i.d. plus metformin 500 mg b.i.d. (S100/M1000), sitagliptin 50 mg b.i.d. plus metformin 850 mg b.i.d. (S100/M1700), or placebo.

resultsThe mean baseline glycated hemoglobin in randomized patients was 8.7%. Least squares mean changes from baseline in glycated hemoglobin were -0.59% (placebo), -0.99% (S100), -1.29% (M1000), -1.56% (M1700), -1.67% (S100/M1000) and -1.83% (S100/M1700) (P < 0.05 for each active group vs placebo, for S100/M1700 and S100/M1000 vs S100, and for S100/M1000 vs M1000). All treatments were generally well-tolerated. The overall incidence of hypoglycemia (symptomatic or asymptomatic) was higher in the two co-administration groups (S100/M1700 and S100/M1000) compared with the placebo. The incidence of symptomatic hypoglycemia was low, and similar, across all treatment groups. The incidences of gastrointestinal adverse events were generally higher in high-dose metformin groups than in the placebo group.

conclusionsIn Chinese patients with type 2 diabetes, initial combination therapy with sitagliptin and metformin was generally well-tolerated, and provided improvement in glycemic control.

Indexed as

ChinaDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMetforminMiddle AgedSitagliptin PhosphateTreatment OutcomeDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminSitagliptin PhosphateDipeptidyl peptidase-4 inhibitorGlycemic controlIncretin therapy

Identifiers

PMID27181998
PMCPMC5009135
OpenAlexW2292689701

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.