Trial reportJournal of diabetes investigation2017

Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes.

R Ravi Shankar, Yuqian Bao, Ping Han, Ji Hu, Jianhua Ma, Yongde Peng, Fan Wu, Lei Xu, Samuel S Engel, Weiping Jia

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2017. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It reports registered trial NCT01590797. Cited by 11 papers.

1number the graph read from it
1cell of the map it votes in
11citing 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 →
-26.50 · no effect
2-h post-meal glucosesitagliptin 100 mg once daily vs placebofavours the treatment · t2dfeeds one cell of the map
Δ -26.5< 0.001
The addition of sitagliptin significantly (P < 0.001) reduced 2-h post-meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo.

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 · 2017
Δ -26.5
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.

NCT01590797 phase3completed

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy, Alone or in Combination With Metformin

Ran2012Enrolled467Registered outcomes5Posted comparisons3ConditionsType 2 Diabetes MellitusArmsInsulin, Metformin, Placebo, Sitagliptin
Open the trial in the graph
5 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Safety and Efficacy of DPP4 Inhibitor and Basal Insulin in Type 2 Diabetes: An Updated Review and Challenging Clinical Scenarios.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Review
  11. Article
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

10 authors.

R Ravi ShankarMerck & Co., Inc., Kenilworth, New Jersey, USA.
Yuqian BaoShanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai.
Ping HanShengjing Hospital of China Medical University, Shenyang.
Ji HuThe Second Affiliated Hospital of Soochow University, Suzhou.
Jianhua MaNanjing First Hospital Affiliated to Nanjing Medical University, Nanjing.
Yongde PengShanghai First People's Hospital affiliated to Shanghai Jiaotong University, Shanghai.
Fan WuMSD China, Beijing, China.
Lei XuMerck & Co., Inc., Kenilworth, New Jersey, USA.
Samuel S EngelMerck & Co., Inc., Kenilworth, New Jersey, USA.
Weiping JiaShanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai.

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

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

introductionWe evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. MATERIALS AND

methodsA total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre-mixed vs intermediate-/long-acting) at screening. The primary end-point was the change from baseline at week 24 in HbA1c.

resultsThe addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly (P < 0.001) reduced 2-h post-meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/dL reduction) and placebo (10.7 mg/dL reduction) groups; the between-group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight.

conclusionsAfter 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus.

Indexed as

Asian PeopleChinaDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleMetforminMiddle AgedSitagliptin PhosphateTreatment OutcomeGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminSitagliptin PhosphateInsulinSitagliptinType 2 diabetes mellitus

Identifiers

PMID27740719
PMCPMC5415484

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.