Evidence map›SGLT2 inhibitors × glycemic control›PMID 34033212›Full record

Trial reportDiabetes, obesity & metabolism2021

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin.

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

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 2 registered trials, which are not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
8citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% 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 →
-0.980 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
reduction -0.77-0.98 to -0.57P <0.001
RESULTS: In Trial 843, baseline characteristics were similar between groups (mean age 60.5 years, HbA1c 8.0%); after 24 weeks, adding ipragliflozin provided significantly greater reduction in HbA1c compared to placebo: least squares mean difference -0.77% (95% confidence interval -0.98, -0.57; P <0.001).
FeedsSGLT2 inhibitors×glycemic control

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.

SGLT2 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 81 favour the treatment, 11 find no difference, 4 favour the comparator.

Belief with this paper
0.92replicated · 70 families support, 6 contradict · against placebo
Without it
0.92This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2021
reduction -0.77-0.98 to -0.57
NCT010326294,330 enrolled · 2009
Δ 2.79-1.57 to 7.15
NCT011374742,996 enrolled · 2010
Δ -0.46-0.59 to -0.33
NCT011956622,245 enrolled · 2010
Δ -0.61-0.76 to -0.46
NCT010956661,484 enrolled · 2010
Δ -0.59-0.76 to -0.42
NCT009688121,452 enrolled · 2009
Δ -0.01-0.11 to 0.09
NCT017190031,413 enrolled · 2012
Adjusted mean -0.33-0.56 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.59-0.81 to -0.37
NCT006732311,240 enrolled · 2008
Δ -0.45-0.59 to -0.31
NCT020991101,233 enrolled · 2014
Δ -0.43-0.60 to -0.27
NCT006609071,217 enrolled · 2008
Δ 0.00-0.11 to 0.11
NCT018093271,186 enrolled · 2013
Δ -0.46-0.66 to -0.27
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.

NCT02564211 phase3completednot on this map

A Phase III, Multicenter, Open-label Long-term Treatment Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2017Enrolled77ConditionsType 2 Diabetes MellitusArmsIpragliflozin, Sitagliptin
NCT02577003 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 Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2016Enrolled143ConditionsType 2 Diabetes MellitusArmsIpragliflozin, Placebo, Sitagliptin
5 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. 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.

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, The University of Tokyo, Tokyo, Japan.
Yutaka SeinoKansai Electric Power Hospital, Osaka, Japan.
Taro OkamotoJapan Development, MSD K.K, Tokyo, Japan.ORCID 0000-0001-5494-462X
Masayoshi ShirakawaJapan Development, MSD K.K, Tokyo, Japan.
Asako SatoJapan 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 · JPToranomon Hospital · JP

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.

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

methodsThe results of two clinical trials are reported. In both trials, patients had glycated haemoglobin (HbA1c) levels of 7.0% to 10.0% on sitagliptin 50 mg once daily 2 weeks prior to addition of ipragliflozin or placebo. In one trial (Trial 843), patients were randomized 1:1 to addition of blinded ipragliflozin 50 mg once daily (n = 73) or placebo (n = 70) for 24 weeks; the primary endpoint was efficacy (change in HbA1c at Week 24). In the other trial (Trial 849), open-label ipragliflozin 50 mg once daily was added for 52 weeks (n = 77); the primary objective was to assess safety/tolerability.

resultsIn Trial 843, baseline characteristics were similar between groups (mean age 60.5 years, HbA1c 8.0%); after 24 weeks, adding ipragliflozin provided significantly greater reduction in HbA1c compared to placebo: least squares mean difference -0.77% (95% confidence interval -0.98, -0.57; P <0.001). In Trial 843, the incidences of adverse events (AEs) overall and prespecified AEs of clinical interest (symptomatic hypoglycaemia, urinary tract infection, genital infection, hypovolaemia, and polyuria/pollakiuria) were similar between groups. In Trial 849, specific AEs with incidence ≥5% were nasopharyngitis, pollakiuria, back pain, thirst, constipation, influenza and arthralgia; drug-related AEs reported in ≥2 patients were pollakiuria, thirst and constipation.

conclusionsIpragliflozin 50 mg once daily added on to sitagliptin 50 mg once daily monotherapy provided significant improvement in glycaemic control and was generally well tolerated in Japanese patients with T2D. ClinicalTrials.gov: NCT02577003, NCT02564211.

Indexed as

Diabetes Mellitus, Type 2MetforminDouble-Blind MethodDrug Therapy, CombinationGlucosidesGlycated HemoglobinGlycemic ControlHumansHypoglycemic AgentsJapanMiddle AgedSitagliptin PhosphateThiophenesTreatment OutcomeGlucosidesGlycated HemoglobinHypoglycemic AgentsipragliflozinMetforminSitagliptin PhosphateThiophenescombination therapyDPP-4 inhibitorincretinsSGLT2 inhibitor

Identifiers

PMID34033212
PMCPMC8453748
OpenAlexW3164908982

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.