Evidence map›Paper›PMID 26701110›Full record

Trial reportCardiovascular diabetology2015

Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial.

Michael Roden, Ludwig Merker, Anita Vedel Christiansen, Flavien Roux, Afshin Salsali, Gabriel Kim, Peter Stella, Hans J Woerle, Uli C Broedl, EMPA-REG EXTEND™ MONO investigators

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
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 is linked to trial NCT01289990 (A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773), which is not on this map. Cited by 64 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 27 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.

NCT01289990 phase3completednot on this map

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled2,705ConditionsDiabetes Mellitus, Type 2ArmsBI 10773, Placebo, Sitagliptin 100mg
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 27 syntheses or guidelines pooled it.

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4 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

10 authors.

Michael RodenDepartment of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. michael.roden@ddz.uni-duesseldorf.de.
Ludwig MerkerDiabetes- und Nierenzentrum, Dormagen, Germany. merker@dialyse-dormagen.de.
Anita Vedel ChristiansenBoehringer Ingelheim Danmark A/S, Copenhagen, Denmark. anita-vedel.christiansen@boehringer-ingelheim.com.
Flavien RouxBoehringer Ingelheim France S.A.S., Reims, France. flavien.roux.ext@boehringer-ingelheim.com.
Afshin SalsaliBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. afshin.salsali@boehringer-ingelheim.com.
Gabriel KimBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. woojae.kim@boehringer-ingelheim.com.
Peter StellaBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. peter.stella.hu@gmail.com.
Hans J WoerleBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. hans-juergen.woerle@boehringer-ingelheim.com.
Uli C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. uli.broedl@boehringer-ingelheim.com.
EMPA-REG EXTEND™ MONO investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo investigate the long-term efficacy and safety of empagliflozin monotherapy compared with placebo and sitagliptin in drug-naïve patients with type 2 diabetes mellitus.

methodsOf 899 patients randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, placebo, or sitagliptin 100 mg once daily for 24 weeks, 615 continued in a double-blind extension trial for ≥52 weeks. Exploratory endpoints included changes from baseline in HbA1c, weight and blood pressure at week 76.

resultsCompared with placebo, adjusted mean changes from baseline in HbA1c at week 76 were -0.78 % (95 % CI -0.94, -0.63; p < 0.001) and -0.89 % (95 % CI -1.04, -0.73; p < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight at week 76 were -1.8 kg (95 % CI -2.4, -1.3; p < 0.001) and -2.0 kg (95 % CI -2.6, -1.5; p < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to reductions in systolic blood pressure (SBP) compared with placebo in the primary analysis but not in sensitivity analyses. Compared with sitagliptin, empagliflozin 25 mg reduced HbA1c and both empagliflozin doses reduced weight and SBP. Adverse events (AEs) were reported in 76.8, 78.0, 76.4 and 72.2 % of patients on empagliflozin 10 mg, empagliflozin 25 mg, placebo and sitagliptin, respectively. Confirmed hypoglycaemic AEs (glucose ≤3.9 mmol/l and/or requiring assistance) were reported in two patients (0.9 %) per treatment group.

conclusionsEmpagliflozin monotherapy for ≥76 weeks was well tolerated and led to sustained reductions in HbA1c and weight compared with placebo.

trial registrationclinicaltrials.gov NCT01289990.

Indexed as

AdultAgedBenzhydryl CompoundsBiomarkersBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedSitagliptin PhosphateTime FactorsBenzhydryl CompoundsBiomarkersBlood GlucoseempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSitagliptin Phosphate

Identifiers

PMID26701110
PMCPMC4690334

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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.