Evidence mapPaperPMID 25633683Full record

Trial reportCardiovascular diabetology2015

Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study.

Rimei Nishimura, Yuko Tanaka, Kazuki Koiwai, Kohei Inoue, Thomas Hach, Afshin Salsali, Søren S Lund, Uli C Broedl

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01947855. Cited by 57 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 6 pooled it
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.

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.

NCT01947855 phase3completed

A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Ran2013Enrolled60Registered outcomes1Posted comparisons2ConditionsDiabetes Mellitus, Type 2Armsempagliflozin, Placebo
Open the trial in the graph
NCT04203927 early_phase1unknown statusstarted 2020, after this paper: background citation

Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes

Ran2020Enrolled50Registered outcomes4Posted comparisons0ConditionsInsulin Sensitivity, Type2 DiabetesArmsempagliflozin 25 mg
Open the trial in the graph
NCT04215445 phase4unknown statusstarted 2019, after this paper: background citation

Effect of Sodium Glucose co Transporter 2 (SGLT2) Inhibition on Optical Coherence Tomography Angiography (OCT-A) Parameters in Diabetic Chronic Kidney Disease (CKD)

Ran2019Enrolled90Registered outcomes3Posted comparisons0ConditionsChronic Kidney Diseases, Diabetes Mellitus, Diabetic RetinopathyArmsempagliflozin 25 mg, OCT-A
Open the trial in the graph
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Article
  20. The Ketogenic Effect of SGLT-2 Inhibitors-Beneficial or Harmful?Journal of cardiovascular development and disease · 2023
    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

8 authors.

Rimei NishimuraJikei University School of Medicine, Tokyo, Japan. rimei.nishimura@gmail.com.
Yuko TanakaNippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. yuko.tanaka@boehringer-ingelheim.com.
Kazuki KoiwaiNippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. kazuki.koiwai@boehringer-ingelheim.com.
Kohei InoueEPS Corporation, Tokyo, Japan. kohei.inoue.ext@boehringer-ingelheim.com.
Thomas HachBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. thomas.hach@boehringer-ingelheim.com.
Afshin SalsaliBoehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA. afshin.salsali@boehringer-ingelheim.com.
Søren S LundBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. soeren.lund@boehringer-ingelheim.com.
Uli C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. Uli.Broedl@boehringer-ingelheim.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM).

methodsPatients (N = 60; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m(2)) were randomized to receive empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19) or placebo (n = 21) once daily as monotherapy for 28 days. A meal tolerance test and continuous glucose monitoring (CGM) for 24 hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast (AUC1-4h for PPG) at day 28.

resultsAdjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were -97.1 (-126.5, -67.8) mg · h/dl with empagliflozin 10 mg and -91.6 (-120.4, -62.8) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -85.5 (-126.0, -45.0) mg · h/dl with empagliflozin 10 mg and -104.9 (-144.8, -65.0) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were -20.8 (-27.0, -14.7) mg/dl with empagliflozin 10 mg and -23.9 (-30.0, -17.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -24.5 (-35.4, -13.6) mg/dl with empagliflozin 10 mg and -31.7 (-42.5,-20.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ≥70 to <180 mg/dl increased from 52.0% at baseline to 77.0% at day 28 with empagliflozin 10 mg and from 55.0% to 81.1% with empagliflozin 25 mg, without increasing time spent with hypoglycemia.

conclusionEmpagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM.

trial registrationClinicaltrials.gov NCT01947855.

Indexed as

Asian PeopleAgedBenzhydryl CompoundsBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucosidesHumansHypoglycemic AgentsMaleMiddle AgedPostprandial PeriodTime FactorsTreatment OutcomeBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesHypoglycemic Agents

Identifiers

PMID25633683
PMCPMC4339254

What Socratic holds

Textmetadata
LicenceCC BY
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.