Evidence map›Paper›PMID 30912033›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2019

Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study.

Yasuo Terauchi, Kazunori Utsunomiya, Atsutaka Yasui, Tetsuo Seki, Gang Cheng, Kosuke Shiki, Jisoo Lee

Registry-linked trialAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02589626. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 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.

NCT02589626 phase4completed

A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control

Ran2015Enrolled65Registered outcomes2Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsempagliflozin 10mg, empagliflozin 25 mg, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Review
  7. Article
  8. Canagliflozin-associated severe hyponatremia: a rare and potentially adverse effect?Endocrinology, diabetes & metabolism case reports · 2022
    Article
  9. Article
  10. Review
  11. Review
  12. SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects.International journal of environmental research and public health · 2019
    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

7 authors.

Yasuo TerauchiDepartment of Endocrinology and Metabolism, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0064, Japan.
Kazunori UtsunomiyaDivision of Diabetes, Metabolism and Endocrinology, The Jikei University School of Medicine, 3-25-8, Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan.
Atsutaka YasuiNippon Boehringer Ingelheim Co. Ltd., ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan. atsutaka.yasui@boehringer-ingelheim.com.
Tetsuo SekiNippon Boehringer Ingelheim Co. Ltd., ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.
Gang ChengBoehringer Ingelheim (China) Investment Co. Ltd, Park Place, 1601 Nanjing Road (West), Shanghai, 200040, People's Republic of China.
Kosuke ShikiNippon Boehringer Ingelheim Co. Ltd., ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.
Jisoo LeeBoehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216, Ingelheim am Rhein, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEmpagliflozin, a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, improves glycaemic control in patients with type 2 diabetes mellitus (T2DM) by inducing urinary glucose excretion. Combination therapy with empagliflozin and glucagon-like peptide-1 (GLP-1) receptor agonists had not previously been assessed, so we investigated the safety, tolerability and efficacy of empagliflozin as an add-on therapy to liraglutide, a GLP-1 receptor agonist.

methodsThis was a randomised, double-blind, parallel-group phase 4 trial of empagliflozin (10 mg or 25 mg) for 52 weeks as an add-on therapy to liraglutide (0.9 mg/day) in Japanese patients with T2DM insufficiently controlled by liraglutide alone.

results59.4% (19/32) and 66.7% (22/33) of patients in the empagliflozin 10 mg and 25 mg groups, respectively, reported at least one adverse event (AE). 9.4% (3/32) and 21.2% (7/33) of patients, respectively, reported drug-related AEs (primary endpoint). From baseline to week 52, adjusted mean changes with empagliflozin 10 mg and 25 mg, respectively, were: - 0.55 (standard error: 0.15) and - 0.77 (0.14)% for glycated haemoglobin; - 32.5 (4.6) and - 36.0 (4.5) mg/dL for fasting plasma glucose; - 2.6 (0.4) and -3.1 (0.3) kg for body weight; - 6.7 (2.2) and - 8.4 (2.1) mmHg for systolic blood pressure; and - 3.0 (1.2) and - 4.7 (1.1) mmHg for diastolic blood pressure.

conclusionEmpagliflozin as an add-on to liraglutide for 52 weeks was well tolerated and led to clinically meaningful and sustained improvements in glycaemic control, body weight and blood pressure in Japanese patients with T2DM.

trial registrationClinicalTrials.gov with the identifier NCT02589626.

fundingNippon Boehringer Ingelheim Co. Ltd.

Indexed as

Add-on therapyEmpagliflozinGLP-1 receptor agonistLiraglutideSodium-glucose cotransporter 2 inhibitorsType 2 diabetes

Identifiers

PMID30912033
PMCPMC6531579

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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 OpenQuestion graph.