Trial reportDiabetes & metabolism journal2023

Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial.

Kyung Ah Han, Yong Hyun Kim, Doo Man Kim, Byung Wan Lee, Suk Chon, Tae Seo Sohn, In Kyung Jeong, Eun-Gyoung Hong, Jang Won Son, Jae Jin Nah and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Diabetes & metabolism journal, 2023. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. It reports registered trial NCT04634500. Cited by 10 papers.

1number the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.4field-weighted citation impact, top 5% 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.

Read, but not usablea number the graph found but could not read as for or against

Glycemic controlcomparator not stated · t2dfeeds one cell of the map
Δ -0.04-0.21 to 0.12
RESULTS: Adjusted mean change of HbA1c at week 24 was -0.80% with enavogliflozin and -0.75% with dapagliflozin (difference, -0.04%; 95% confidence interval, -0.21% to 0.12%).

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

No readable resultOpen 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 itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
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

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

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.

NCT04634500 phase3completed

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Ran2020Enrolled200Registered outcomes1Posted comparisons0ConditionsT2DM (Type 2 Diabetes Mellitus)Armsdapagliflozin
Open the trial in the graph
5 · Its place in the literature

Who cites it

10 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
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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

14 authors at 11 institutions in 1 country.

Kyung Ah HanDivision of Endocrinology and Metabolism, Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, Korea.
Yong Hyun KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Bundang Jesaeng Hospital, Seongnam, Korea.
Doo Man KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Seoul, Korea.
Byung Wan LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Suk ChonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.
Tae Seo SohnDivision of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.
In Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Eun-Gyoung HongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Jang Won SonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.
Jae Jin NahClinical Development Center, Daewoong Pharmaceutical Co. Ltd., Seoul, Korea.
Hwa Rang SongClinical Development Center, Daewoong Pharmaceutical Co. Ltd., Seoul, Korea.
Seong In ChoClinical Development Center, Daewoong Pharmaceutical Co. Ltd., Seoul, Korea.
Seung-Ah ChoClinical Development Center, Daewoong Pharmaceutical Co. Ltd., Seoul, Korea.
Kun Ho YoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Daewoong Pharmaceutical (South Korea) · KRBundang Jesaeng Hospital · KREulji University · KRHallym University Dongtan Sacred Heart Hospital · KRKangdong Sacred Heart Hospital · KRKyung Hee University · KRKyung Hee University Hospital at Gangdong · KRThe Catholic University of Korea Bucheon St. Mary's Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRThe Catholic University of Korea Uijeongbu St. Mary's Hospital · KRYonsei University · KR

Funding

Daewoong Pharmaceutical Co. Ltd.
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgruoundEnavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin.

methodsIn this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500).

resultsAdjusted mean change of HbA1c at week 24 was -0.80% with enavogliflozin and -0.75% with dapagliflozin (difference, -0.04%; 95% confidence interval, -0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was -32.53 and -29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (-1.85 vs. -1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (-3.77 kg vs. -3.58 kg) and blood pressure (systolic/diastolic, -5.93/-5.41 mm Hg vs. -6.57/-4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated.

conclusionEnavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone.

Indexed as

Diabetes Mellitus, Type 2MetforminSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsBlood GlucoseGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminSodium-Glucose Transporter 2 InhibitorsDapagliflozinDiabetes mellitus, type 2Hypoglycemic agentsMetforminRandomized controlled trialSodium-glucose transporter 2 inhibitors

Identifiers

PMID36756676
PMCPMC10695710
OpenAlexW4319656991

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.