Evidence map›Paper›PMID 41397686›Full record

Trial reportDiabetes & metabolism journal2026

Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs.

Jun Hwa Hong, Kyung Wan Min, Chang Beom Lee, Parinya Chamnan, Thanitha Sirirak, Kiran Sony, Sarinya Sattanon, Hae Jin Kim, Sang-Yong Kim, Younghee Kim and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Diabetes & metabolism journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05466643 (A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus), which is not on this map. Not yet cited in PubMed.

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

NCT05466643 phase3unknown statusnot on this map

A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorDaewoong Pharmaceutical Co. LTD.Ran2023 to 2024Enrolled240ConditionsType 2 Diabetes MellitusArmsDWP16001 0.3mg, DWP16001 Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Jun Hwa HongDepartment of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea.
Kyung Wan MinDepartment of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, Korea.
Chang Beom LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
Parinya ChamnanCardiometabolic Research Group, Department of Social Medicine, Sunpasitthiprasong Hospital, Ubon Ratchathani, Thailand.
Thanitha SirirakDepartment of Family Medicine and Preventive Medicine, Faculty of Medicine, Songklanagarind Hospital, Songkhla, Thailand.
Kiran SonyDepartment of Medicine, Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.
Sarinya SattanonDepartment of Medicine, Faculty of Medicine, Naresuan University Hospital, Phitsanulok, Thailand.
Hae Jin KimDepartment of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Sang-Yong KimDepartment of Internal Medicine, Chosun University Hospital, Gwangju, Korea.
Younghee KimDaewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Jung A HeoDaewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Jae Min ChoDaewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Jae Jin NahDaewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Mi Hee ParkDaewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Jae Hyeon KimDepartment of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jaehyeonkim26@gmail.com.

Funding

Daewoong Pharmaceutical Co., Ltd
6 · The paper itself

Abstract

backgruoundThe study evaluated the efficacy and safety of enavogliflozin, a novel, promising selective sodium-glucose cotransporter 2 inhibitor, as an add-on in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with insulin alone or combined with other antidiabetic drugs (OADs).

methodsThe double-blind, placebo-controlled, multicenter trial was conducted in South Korea and Thailand. Individuals with glycosylated hemoglobin (HbA1c) ≥7.5% after ≥8-week treatment with background insulin alone or combined with ≤2 OADs were randomized to receive enavogliflozin 0.3 mg or placebo (n=120 each) for 24 weeks. The primary outcome was a change in HbA1c at week 24. Secondary outcomes included, among others, changes in body weight, blood pressure, and other measures of glycemic control. Adverse events (AEs) were investigated throughout the study (Clinical trial registration number: NCT05466643).

resultsAt week 24, the placebo-adjusted mean change in HbA1c from baseline in the enavogliflozin group was -0.9% (P<0.001). Also, placebo-adjusted mean changes in fasting plasma glucose (-32.4 mg/dL, P<0.001), body weight (-1.3 kg, P<0.001), and total daily dose of insulin (-1.3 units, P=0.010) at week 24 were statistically significant. In addition, a significant decrease in blood pressure and fasting C-peptide was observed in the enavogliflozin group, along with a significant increase in homeostasis model assessment of β-cell function, yet without a concomitant change in homeostasis model assessment of insulinresistance. No significant increase in treatment-related AEs was observed for enavogliflozin.

conclusionEnavogliflozin 0.3 mg/day is an efficacious and safe add-on treatment option in T2DM patients controlled inadequately with insulin alone or combined with OADs.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2Hypoglycemic AgentsInsulinSodium-Glucose Transporter 2 InhibitorsAdultAgedBenzofuransBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansMale6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsBenzofuransBlood GlucoseEnavogliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinSodium-Glucose Transporter 2 InhibitorsDiabetes mellitus, type 2Hypoglycemic agentsInsulinRandomized controlled trialSodium-glucose transporter 2 inhibitors

Identifiers

PMID41397686
PMCPMC13561644

What Socratic holds

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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 Socratic graph.