Evidence map›Paper›PMID 24722494›Full record

Trial reportDiabetes care2014

Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.

Hans-Ulrich Häring, Ludwig Merker, Elke Seewaldt-Becker, Marc Weimer, Thomas Meinicke, Uli C Broedl, Hans J Woerle, EMPA-REG MET Trial Investigators

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02798744 (SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation), which is not on this map. Cited by 171 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
171citing papers in PubMed, 23 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.

NCT02798744 phase4completedstarted 2016, after this paper: background citation

SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)

Ran2016Enrolled68Registered outcomes15Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsdiet, empagliflozin, Placebo
PMID 23398530PMID 24948511PMID 24463448PMID 22238392PMID 23963895PMID 23906415PMID 24929430PMID 24463454PMID 24622369PMID 24622320PMID 24026259PMID 23617798other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

171 citing papers in PubMed, 23 syntheses or guidelines pooled it.

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111 more citing papers are in PubMed but not listed here.

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.

Hans-Ulrich HäringUniversity of Tübingen, Tübingen, Germany hans-ulrich.haering@med.uni-tuebingen.de.
Ludwig MerkerDiabetes-und Nierenzentrum, Dormagen, Germany.
Elke Seewaldt-BeckerBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Marc WeimerBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Thomas MeinickeBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Uli C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Hans J WoerleBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
EMPA-REG MET Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy and tolerability of empagliflozin as an add-on to metformin therapy in patients with type 2 diabetes. RESEARCH DESIGN AND

methodsPatients with HbA1c levels of ≥7% to ≤ 10% (≥53 to ≤86 mmol/mol) while receiving metformin (≥1,500 mg/day) were randomized and treated with once-daily treatment with empagliflozin 10 mg (n = 217), empagliflozin 25 mg (n = 213), or placebo (n = 207) for 24 weeks. The primary end point was the change in HbA1c level from baseline at week 24. Key secondary end points were changes from baseline in weight and mean daily glucose (MDG) at week 24.

resultsAt week 24, adjusted mean (SE) changes from baseline in HbA1c were -0.13% (0.05)% (-1.4 [0.5] mmol/mol) with placebo, -0.70% (0.05)% (-7.7 [0.5] mmol/mol) with empagliflozin 10 mg, and -0.77% (0.05)% (-8.4 [0.5] mmol/mol) with empagliflozin 25 mg (both P < 0.001). Empagliflozin significantly reduced MDG level and systolic and diastolic blood pressure (BP) versus placebo. Adjusted mean (SE) changes from baseline in weight were -0.45 kg (0.17 kg) with placebo, -2.08 kg (0.17 kg) with empagliflozin 10 mg, and -2.46 kg (0.17 kg) with empagliflozin 25 mg (both P < 0.001). Adverse events (AEs) were similar across groups (placebo 58.7%; empagliflozin 49.5-57.1%). Confirmed hypoglycemic AEs were reported in 0.5%, 1.8%, and 1.4% of patients receiving placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively. Events consistent with urinary tract infections were reported in 4.9%, 5.1%, and 5.6% of patients, and events consistent with genital infections were reported in 0%, 3.7%, and 4.7% of patients, respectively.

conclusionsEmpagliflozin 10 and 25 mg for 24 weeks as add-on to metformin therapy significantly improved glycemic control, weight, and BP, and were well-tolerated.

Indexed as

Benzhydryl CompoundsBlood GlucoseBlood PressureBody WeightCohort StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMaleBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsMetformin

Identifiers

PMID24722494

What Socratic holds

Texttitle and abstract
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.