Evidence map›Paper›PMID 41175321›Full record

ArticleAdvances in therapy2025

ADD2Dia: Real-World Clinical Effectiveness of Adding a Sodium-Glucose Cotransporter 2 Inhibitor to Gliclazide-Based Therapy in Type 2 Diabetes.

Rodrigo O Moreira, Nemencio A Nicodemus, Abdurrahman Comlekci, Miao Yu, Mussa H Almalki

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06708091 (A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT06708091 completednot on this map

A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release

TypeobservationalSponsorServier Affaires MédicalesRan2022 to 2024Enrolled537ConditionsType 2 Diabetes
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

5 authors.

Rodrigo O MoreiraInstituto Estadual de Diabetes e Endocrinologia Luiz Capriglione (IEDE), Rua Moncorvo Filho 90, Rio de Janeiro, CEP 20211-340, Brazil. rodrigomoreira@unipac.br.ORCID http://orcid.org/0000-0003-1561-2926
Nemencio A NicodemusUniversity of the Philippines-College of Medicine, Manila, Philippines.
Abdurrahman ComlekciDokuz Eylul University Medical School, Izmir, Turkey.
Miao YuPeking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Mussa H AlmalkiObesity, Endocrine, and Metabolism Centre, King Fahad Medical City, Second Cluster, Riyadh, Saudi Arabia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study investigated the real-world clinical effectiveness and tolerability of adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) to gliclazide modified release (MR)-based therapy in a sample of patients with type 2 diabetes (T2D) across five countries, and its value as an effective and well-tolerated strategy in T2D management in a diverse patient population, including those at high risk.

methodsThis non-interventional, retrospective chart review study included patients with T2D treated with gliclazide MR-based therapy and an SGLT2i for at least 60 days. The primary outcome was change in glycated hemoglobin (HbA1c) levels. Secondary outcomes included treatment patterns, proportion of patients achieving an HbA1c target < 7%, changes in lipid profile, blood pressure, weight, new-onset comorbidities, and adverse events of special interest (AESI).

resultsA total of 537 patients (47.7% female, mean age of 59.2 years, mean disease duration 10.0 years) were included, of whom 75.4% were obese/overweight and 15.1% had atherosclerotic cardiovascular disease (ASCVD). At baseline, HbA1c was uncontrolled (≥ 7%) in 87.2% of patients (mean HbA1c of 8.7% [SD 1.7]). Mean HbA1c reductions were - 1.1% (SD 1.8) at 6 months, - 0.7% (SD 1.9) at 2.4 years, and - 0.6% (SD 1.7) at 3 years. The proportion of patients with HbA1c < 7% increased from 12.8% at baseline to 29.3% at least once during follow-up. Mean body weight decreased by 1.7 kg (95% CI - 2.2, - 1.3). AESIs were reported in 40 patients (7.4%) with urinary tract infections being the most common (6.8%).

conclusionThe first real-world study of the long-term combination of gliclazide MR and SGLT2i demonstrated its value as an effective and well-tolerated strategy in T2D management, particularly in high-risk populations. This combination provided clinically meaningful and sustained HbA1c reductions and improved cardiometabolic parameters in a diverse T2D population, with very few adverse events. These results align with current guidelines emphasizing the importance of early combination treatment and multifactorial risk management in T2D and highlight the need to address late treatment intensification indicative of clinical inertia.

trial registrationClinicalTrials.gov Identifier NCT06708091.

Indexed as

Diabetes Mellitus, Type 2GliclazideHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsAgedDrug Therapy, CombinationFemaleGlycated HemoglobinHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeGliclazideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsCombination treatmentGliclazide MRHbA1cReal-worldSGLT2iType 2 diabetes

Identifiers

PMID41175321
PMCPMC12618437

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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.