Evidence map›Paper›PMID 42221148›Full record

ReviewDiabetes, metabolic syndrome and obesity : targets and therapy2026

The Efficacy and Safety of Teplizumab in the Treatment of Stage 3 Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Qiu Sun, Gang Zhao

Abstract readReview
In one paragraph

Review in Diabetes, metabolic syndrome and obesity : targets and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

2 authors.

Qiu SunSurgical Teaching and Research Office, Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.
Gang ZhaoSurgical Teaching and Research Office, Heilongjiang University of Chinese Medicine, Harbin, People's Republic of China.ORCID 0009-0004-4172-087X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: After diagnosis of stage 3 type 1 diabetes, β-cell decline persists, and intensive insulin therapy alone still fails to control metabolic fluctuations and acute risks; teplizumab may delay decline, but trial findings are inconsistent, necessitating a systematic review of efficacy and safety. Objective: To evaluate the efficacy and safety of teplizumab for stage 3 type 1 diabetes from randomized controlled trials and to determine the certainty and applicability of the evidence. Methods: PubMed, Embase, Cochrane Library, and Web of Science were searched up to October 31, 2025, including parallel RCTs comparing intravenous teplizumab monotherapy with placebo/standard care. The primary outcome was preservation of MMTT C-peptide AUC at 9-15 months (SMD), with assessment at 18-24 months; secondary outcomes were insulin dose and HbA1c (MD), and partial remission (RR, IDAA1c≤9). Risk of bias was assessed using RoB 2; random-effects meta-analysis was performed, and subgroup, sensitivity, and GRADE assessments were conducted. Results: Five double-blind, placebo-controlled RCTs were included (975 analyzed), with overall low risk of bias. Teplizumab improved C-peptide AUC preservation at 9-15 months (SMD=0.28, 95% CI 0.09-0.48, P=0.016; exceeded MCID 0.20), and showed only a favorable trend at 18-24 months (SMD=0.27, 95% CI -0.02-0.56). It also reduced insulin dose (MD=-0.11 U/kg/day) and HbA1c (MD=-0.22%), and increased partial remission rate (RR=1.39). For safety, immune-related events increased (lymphopenia RR=3.36, infusion-related reactions RR=2.79), whereas infection (RR=0.98) and diabetic ketoacidosis (RR=0.80) showed no apparent difference, and severe hypoglycemia decreased (RR=0.67). GRADE indicated moderate certainty for short-term outcomes, and low certainty for long-term C-peptide and some acute events. Conclusion: Teplizumab was associated with preservation of β-cell function and modest metabolic benefit, with immune-related reactions as the main risk and no increase in serious clinical events observed; long-term benefits remain to be confirmed.

Indexed as

meta-analysisrandomized controlled trialteplizumabtype 1 diabetes

Identifiers

PMID42221148
PMCPMC13217445

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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.