Trial reportDiabetes, obesity & metabolism2021

A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin.

Yutaka Seino, Kohei Kaku, Takashi Kadowaki, Taro Okamoto, Asako Sato, Masayoshi Shirakawa, Edward A O'Neill, Samuel S Engel, Keith D Kaufman

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to trial NCT02577016 (A Phase III, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial to Assess the Safety and Efficacy of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin Monotherapy in Addition to Diet and Exercise Therapy), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
1cell of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 43% 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.

← favours the treatmentfavours the comparator →
-1.050 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ -0.83-1.05 to -0.62P <0.001
After 24 weeks, the addition of sitagliptin provided significantly greater reduction in HbA1c compared to placebo (least squares [LS] mean difference -0.83% [95% confidence interval -1.05, -0.62]; P <0.001).

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 · 2021
Δ -0.83-1.05 to -0.62
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.

NCT02577016 phase3completednot on this map

A Phase III, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial to Assess the Safety and Efficacy of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin Monotherapy in Addition to Diet and Exercise Therapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2016Enrolled141ConditionsType 2 Diabetes MellitusArmsSitagliptin, Placebo, Ipragliflozin
5 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

9 authors at 5 institutions in 2 countries.

Yutaka SeinoKansai Electric Power Hospital, Osaka, Japan.
Kohei KakuKawasaki Medical School, Okayama, Japan.ORCID 0000-0003-1574-0565
Takashi KadowakiDepartment of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Taro OkamotoJapan Development, MSD K.K., Tokyo, Japan.ORCID 0000-0001-5494-462X
Asako SatoJapan Development, MSD K.K., Tokyo, Japan.
Masayoshi ShirakawaJapan Development, MSD K.K., Tokyo, Japan.
Edward A O'NeillMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Samuel S EngelMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.ORCID 0000-0002-4439-6356
Keith D KaufmanMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMSD K.K. (Japan) · JPKansai Electric Power (Japan) · JPKawasaki Medical School · JPTokyo University of Pharmacy and Life Sciences · JP

Funding

The study was funded and conducted by MSD K.K., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA., as a joint development program with Astellas Pharma Inc
8 · The paper itself

Abstract

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

aimsTo investigate the efficacy, safety and tolerability of sitagliptin 50 mg once daily added to ipragliflozin 50 mg once daily monotherapy in Japanese patients with type 2 diabetes (T2D). MATERIALS AND

methodsJapanese patients with T2D and glycated haemoglobin (HbA1c) 7.0% to 10.0% while treated with ipragliflozin 50 mg once daily were randomized 1:1 to additional treatment with sitagliptin 50 mg once daily (N = 70) or matching placebo (N = 71) for 24 weeks. The primary efficacy endpoint was change in HbA1c at Week 24. Secondary efficacy endpoints were changes in 2-hour post-meal glucose (PMG), total PMG 0- to 2-hour area under the curve (AUC

resultsBaseline characteristics were similar in the two groups (mean age 55.5 years, mean baseline HbA1c 8.0%). After 24 weeks, the addition of sitagliptin provided significantly greater reduction in HbA1c compared to placebo (least squares [LS] mean difference -0.83% [95% confidence interval -1.05, -0.62]; P <0.001). Significant reductions were also observed in all secondary endpoints: LS mean differences from placebo in changes in 2-hour PMG, total PMG AUC

conclusionsIn Japanese patients with T2D, sitagliptin 50 mg once daily added to ipragliflozin 50 mg once daily monotherapy provided significant improvement in glycaemic control and was generally well tolerated. ClinicalTrials.gov: NCT02577016.

Indexed as

Diabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsMetforminDouble-Blind MethodDrug Therapy, CombinationGlucosidesGlycated HemoglobinGlycemic ControlHumansHypoglycemic AgentsJapanMiddle AgedSitagliptin PhosphateThiophenesTreatment OutcomeDipeptidyl-Peptidase IV InhibitorsGlucosidesGlycated HemoglobinHypoglycemic AgentsipragliflozinMetforminSitagliptin PhosphateThiophenescombination therapyDPP-4 inhibitorincretinsSGLT2 inhibitor

Identifiers

PMID33565686
PMCPMC8248366
OpenAlexW3128313473

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.