Evidence map›Paper›PMID 41269878›Full record

Trial reportJournal of diabetes investigation2026

Efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 vs originator insulin degludec/insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open-label, phase 3 study.

Leili Gao, Zhifeng Cheng, Guoqing Ma, Xiaojun Cai, Xiaoyun Wang, Yibing Lu, Ziling Li, Wei Li, Shuping Zhao, Xuefeng Li and 6 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

16 authors.

Leili GaoDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Zhifeng ChengFourth Affiliated Hospital of Harbin Medical University, Harbin, China.
Guoqing MaThe Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, China.
Xiaojun CaiTraditional Chinese Medicine Academy of Heilongjiang, Harbin, China.
Xiaoyun WangCangzhou Hospital of Integrated TCM-WM Hebei, Cangzhou, China.
Yibing LuThe Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Ziling LiBaogang Hospital of Inner Mongolia, Baotou, China.
Wei LiYanan University Affiliated Hospital, Yanan, China.
Shuping ZhaoTonghua Central Hospital, Tonghua, China.
Xuefeng LiTaihe Hospital, Shiyan, China.
Chengwei SongJilin Province FAW General Hospital, Changchun, China.
Yunming GaoThe Second People's Hospital of Lianyungang, Lianyungang, China.
Jianlin GengHarrison International Peace Hospital, Hengshui, China.
Haiyan CaoHui Sheng Bio-pharmaceutical Co., Ltd, Meihekou, China.
Jingfang SunHui Sheng Bio-pharmaceutical Co., Ltd, Meihekou, China.
Linong JiDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Funding

Hui Sheng Bio-pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

aimsTo compare the efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 (HS-IDegAsp) with originator insulin degludec/insulin aspart-Ryzodeg (NN-IDegAsp) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once- or twice-daily (BID) premixed or basal insulin ± oral antidiabetic drugs (OADs). MATERIALS AND

methodsIn this multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS-IDegAsp (n = 183) or NN-IDegAsp (n = 184) for 24 weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hemoglobin (HbA

resultsAt Week 24, the least squares (LS) mean change in HbA

conclusionsHS-IDegAsp demonstrated comparable efficacy and safety to NN-IDegAsp during the 24-week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once- or twice-daily premixed or basal insulin, with or without OADs.

Indexed as

Biosimilar PharmaceuticalsDiabetes Mellitus, Type 2Hypoglycemic AgentsInsulin AspartInsulin, Long-ActingAdultAgedBlood GlucoseChinaDrug CombinationsFemaleGlycated HemoglobinHumansMaleMiddle AgedTreatment OutcomeBiosimilar PharmaceuticalsBlood GlucoseDrug CombinationsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin Aspartinsulin degludec, insulin aspart drug combinationInsulin, Long-ActingBiosimilar insulinInsulin degludec/insulin aspartType 2 diabetes

Identifiers

PMID41269878
PMCPMC12757660

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.