1. Background
Type 2 diabetes (T2D) represents a major public health challenge across Latin America (LATAM) [1, 2]. As per the International Diabetes Federation 2025 reports, the age‐adjusted comparative prevalence of diabetes in individuals aged 20–79 years is 8.4% in Colombia and 16.4% in Mexico, with a significant proportion of undiagnosed cases (16.2% and 41.3%, respectively) in 2024 [3]. Additionally, a 2024 study found 11% T2D prevalence in Bogotá [4].
In the LATAM region, < 55% people with T2D achieve their glycaemic targets, defined as glycated haemoglobin (HbA1c) level < 7% or fasting plasma glucose (FPG) level < 126 mg/dL, even after receiving antidiabetic treatment [5]. The 2022 International societies consensus recommends fixed‐ratio combination (FRC) therapy with basal insulin (BI) and glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) for individuals failing to achieve their treatment goals with other therapies [1, 6]. iGlarLixi is a once‐daily FRC therapy combining insulin glargine (iGlar; 100 U/mL) and lixisenatide (Lixi)—possessing complementary mechanisms—that lowers FPG and postprandial glucose (PPG) levels [7, 8, 9, 10, 11, 12]. This reduces injection burden and offers advantages over multiple daily insulin regimens and premix insulin, which are associated with increased hypoglycaemia risk, weight gain and adherence challenges [10, 12]. iGlarLixi's effectiveness and safety in T2D have been demonstrated through randomised controlled trials (RCTs) [13, 14, 15, 16] across diverse patient populations, with real‐world evidence (RWE) [17] providing additional insights from broader clinical practice settings.
The real‐world SUCCESS study (OBS16039) demonstrated improved glycaemic control with low hypoglycaemia incidence and no weight gain after iGlarLixi initiation in people with T2D inadequately controlled on oral antidiabetic drugs (OADs) ± BI/GLP‐1 RAs [18]. This regional subanalysis of SUCCESS aimed to evaluate iGlarLixi's impact on glycaemic management in participants with T2D from the LATAM region in real‐world settings.
2. Methods
SUCCESS was a 12‐month international, prospective, observational study evaluating the real‐world effectiveness and safety of iGlarLixi following OAD failure (alone or with BI/GLP‐1 RAs) in patients with T2D. The current regional subanalysis of SUCCESS evaluated the effectiveness and safety of iGlarLixi in participants with T2D from Colombia and Mexico, henceforth referred to as the LATAM region (SUCCESS LATAM). The study design (Figure S1) and primary results have been published [18]. Participants were identified from the global SUCCESS cohort (N = 782) based on country of enrolment (Colombia and Mexico for LATAM region), with inclusion/exclusion criteria as defined in the primary publication [18]. The subanalysis enrolled 119 adults (aged ≥ 18 years) with T2D who initiated iGlarLixi within 1 month prior to inclusion. Data were collected at baseline and Months 3, 6 and 12 (Figure S1) via self‐measured plasma glucose (SMPG), patient diaries and questionnaires. The study followed the standards of Good Epidemiology Practice and the principles of the Declaration of Helsinki; all participants provided informed consent.
The primary endpoint was the change in baseline HbA1c level at post‐treatment Month 6; the secondary endpoints are summarised in Table S1. Adverse and serious adverse events were monitored through routine clinical practice rather than a structured pharmacovigilance protocol. The Treatment‐Related Impact Measure for Diabetes (TRIM‐D) was used to assess T2D treatment impact on patient‐reported outcomes (PROs). The TRIM‐D is a validated patient‐reported outcome instrument comprising 28 items across five domains, with scores ranging from 0 to 100, where higher scores indicate a greater positive treatment impact on daily functioning and well‐being [19]. Treatment effectiveness was assessed using the Patient's Global Treatment Effectiveness Evaluation (GTEE) scale, which provided insights from participants and physicians.
Precision was assessed using the two‐sided 95% confidence interval (CI) for the least square (LS) mean change in baseline HbA1c level at Month 6. The primary endpoint was analysed using a mixed‐effects model for repeated measures (MMRM), with visit (Months 3, 6 and 12) as a fixed categorical effect and baseline HbA1c level as a fixed continuous covariate, providing baseline‐adjusted LS mean estimates and 95% CIs under the missing‐at‐random assumption. The secondary effectiveness endpoints were reported as percentages with 95% CIs for binary outcomes, and they were analysed via the MMRM approach used for continuous variables. iGlarLixi usage and safety variables were summarised using descriptive statistics.
3. Results
The study included 119 (16.15%) participants from Colombia (n = 55) and Mexico (n = 64). The eligible and safety populations comprised all participants; the evaluable population included 118 (99.1%) participants (One participant was excluded because he/she did not fall under the “Evaluable Population” criteria). Of the eligible population, 117 (98.3%) and 114 (95.7%) participants completed 6‐ and 12‐month follow‐up, respectively (Figure S2).
The baseline demographics and clinical characteristics are presented in Table 1. The baseline HbA1c level among the evaluable participants (mean ± standard deviation [SD]) was 9.8% ± 2.1%, which decreased to 8.2% ± 1.8% at Month 6. The LS mean change in baseline HbA1c level (primary endpoint) at Month 6 was −1.57% (standard error: 0.17; 95% CI: −1.91, −1.22; Figure 1A). At Month 12, HbA1c level further decreased (8.1% ± 1.9%), with the LS mean change decreasing to −1.69% ± 0.19% (95% CI: −2.07, −1.32; Figure 1A). At Month 6, 32.71% participants achieved their individualised HbA1c targets, which increased to 38.32% by Month 12, indicating improved glycaemic control over time (Figure 1B). Additionally, FPG and PPG levels improved with meaningful reductions from baseline to Months 6 and 12 (Figure S3).
TABLE 1.
Demographic and baseline characteristics (eligible population).
| Baseline characteristics | LATAM (N = 119) |
|---|---|
| Age, years, mean (SD) | 58.6 (11.7) |
| Age group, years, n (%) | |
| < 65 | 76 (63.9) |
| 65–75 | 35 (29.4) |
| ≥ 75 | 8 (6.7) |
| Sex, n (%) | |
| Male | 57 (47.9) |
| Female | 62 (52.1) |
| Weight (kg), mean (SD) | 80.6 (18.0) |
| BMI, kg/m2, mean (SD) | 30.1 (6.0) |
| BMI, kg/m2, n (%) | |
| < 25 | 23 (19.8) |
| 25–30 | 41 (35.3) |
| 30–35 | 31 (26.7) |
| ≥ 35 | 21 (18.1) |
| Duration of diabetes, years, mean (SD) | 13.2 (8.7) |
| Duration of diabetes, years, n (%) | 16 (13.4) |
| 1–5 | 32 (26.9) |
| 5–10 | 71 (59.7) |
| ≥ 10 | |
| Age of onset of diabetes, years, mean (SD) | 47.4 (11.7) |
| Mean time since first intake of anti‐hyperglycaemic therapy, years, mean (SD) | 12.5 (8.2) |
| Any diabetes complications, n (%) | 39 (32.8) |
| Diabetic neuropathy | 21 (17.6) |
| Diabetic retinopathy | 18 (15.1) |
| Diabetic nephropathy | 15 (12.6) |
| iGlarLixi dose at baseline (U), mean (SD) | 21.7 (9.8) |
| HbA1c level (%), mean (SD) | 9.8 (2.1) |
| FPG level (mg/dL), mean (SD) | 181.4 (58.2) |
| Postprandial SMPG level (mg/dL), mean (SD) | 198.4 (62.5) |
| Prior other OAD use, n (%) | |
| None | 17 (14.3) |
| 1 | 18 (15.1) |
| 2 | 23 (19.3) |
| ≥ 3 | 61 (51.3) |
| Antidiabetic medication prior to iGlarLixi initiation, n (%) | |
| Any antidiabetic non‐insulin medication | 96 (80.7) |
| Biguanides | 86 (72.3) |
| Sulfonylurea | 15 (12.6) |
| DPP‐4 inhibitors | 41 (34.5) |
| SGLT‐2 inhibitors | 41 (34.5) |
| Thiazolidinedione | 1 (0.8) |
| GLP‐1 RA | 6 (5.0) |
Abbreviations: BMI, body mass index; DPP‐4, dipeptidyl peptidase‐4; FPG, fasting plasma glucose; GLP‐1 RA, glucagon‐like peptide‐1 receptor agonist; HbA1c, glycated haemoglobin; iGlarLixi, a fixed‐ratio combination of insulin glargine 100 U/mL and the glucagon‐like peptide‐1 receptor agonist lixisenatide; LATAM, Latin America; N, eligible population; n (%), number and percentage; OAD, oral antidiabetic drug; SD, standard deviation; SGLT‐2, sodium/glucose cotransporter‐2; SMPG, self‐measured plasma glucose.
FIGURE 1.
(A) Change in HbA1c level (%) from baseline to Month 6 (evaluable population) and (B) HbA1c target achievement at Months 6 and 12 (eligible population). HbA1c, glycated haemoglobin; LS, least squares; N, eligible population; SE, standard error.
In the eligible population, the baseline body weight (mean ± SD: 80.6 ± 18.0 kg; 95% CI: 77.3, 83.9) decreased to 78.6 ± 16.2 kg (95% CI: 75.6, 81.6) and 77.5 ± 15.8 kg (95% CI: 74.6, 80.5) at Months 6 and 12, respectively (Figure S4). Few participants reported confirmed symptomatic hypoglycaemia events (n = 14 and n = 3 for blood glucose < 70 mg/dL [< 3.9 mmol/L] and < 54 mg/dL [< 3.0 mmol/L], respectively), with no severe hypoglycaemia episodes reported (Table S2). The mean daily iGlarLixi dose increased from 21.7 U at baseline to 26.9 U at Month 12 (Figure S5). iGlarLixi treatment was well‐tolerated; only 36 (30.3%) participants reported ≥ 1 adverse event (Table S3), and PROs improved. TRIM‐D scores rose from 61.1 ± 8.6 (baseline) to 66.5 ± 7.6 (Month 12) across all domains (Figure S6). At Month 12, 64.3% of patients and 60.7% of physicians reported complete/marked glucose control (GTEE scale); 2.7% reported worsening (Figure S7).
4. Discussion
This subanalysis demonstrated results consistent with the global SUCCESS study findings, showing meaningful glycaemic improvements with low hypoglycaemia incidence and minimal weight gain. The results also support the findings from other RCTs (LixiLan‐L [13], LixiLan‐O [14], SoliMix [15], Soli‐D [16], LixiLan‐G extension study) [20] and RWE studies with both FRCs (ASSIGLIX‐MX [8], SoliComplex [9], SPIRIT study) [21], confirming that the trial‐observed glycaemic improvements translate to real‐world settings.
iGlarLixi has demonstrated durable glycaemic efficacy and safety, with reduced HbA1c levels sustained up to 52 weeks in RCTs [20] and extended across 24 months in RWE studies [22], without any increase in body weight and hypoglycaemia rates. In this subanalysis, reduction in HbA1c levels at Months 6 and 12 (−1.57% and −1.69%, respectively) was comparable or slightly higher versus SUCCESS (−1.44% and −1.64%, respectively) [18]. These findings align with those from other real‐world studies and RCTs, including ASSIGLIX‐MX [8], SPIRIT [21], LixiLan‐O [14] and Soli‐D [16].
Additionally, HbA1c target achievement rates were comparable versus SUCCESS, but were lower versus the aforementioned RCTs. This is likely due to the higher baseline HbA1c level (9.8%) and suboptimal titration in this study, suggesting potentially improved outcomes with optimal titration of iGlarLixi and more frequent follow‐up visits. Moreover, the mean iGlarLixi dose increased from 21.7 U (baseline) to 26.9 U (Month 12), a modest increase compared to that of RCTs reaching 40–45 U/day [13, 20], indicating titration inertia; thus, aggressive dose optimisation could potentially drive greater reduction in HbA1c levels.
The safety profile was consistent with that of previous RCTs and RWE studies with low hypoglycaemia risk, which was attributed to the synergistic effects from BI/GLP‐1 RAs.
In addition, iGlarLixi presented a slight reduction in body weight, comparable with previous studies [13, 15], thus making FRCs suitable alternatives when trying to avoid weight gain.
The primary strength of this study was its prospective, real‐world design, enabling real‐time data collection in diverse clinical settings and RWE contribution from the LATAM region to support global understanding of the iGlarLixi therapy. Its limitations included lack of comparator arm and randomisation. Also, standardised lifestyle counselling was not provided, and dietary/physical activity data were not collected or adjusted for this subanalysis. The subanalysis was limited to Colombia and Mexico; as LATAM encompasses additional countries, geographic representation is restricted. However, it may provide direction for future, broader analyses across the LATAM region. Inconsistent data availability across endpoints—with smaller sample sizes for FPG (N = 70) and PPG (N = 44) compared to HbA1c (N = 118)—may introduce selection bias and affect secondary outcome interpretation. MMRM analysis adjusted only for baseline HbA1c (excluding body mass index and diabetes duration due to data unavailability), potentially affecting treatment response interpretation given the 13.2‐year mean diabetes duration. Most participants (95%) were GLP‐1 RA–naïve; iGlarLixi was their first GLP‐1 RA therapy, explaining the substantial glycemic improvement. Real‐world studies in GLP‐1 RA–experienced patients would clarify its effectiveness across treatment stages.
5. Conclusion
In the LATAM region, iGlarLixi initiation in people with T2D inadequately controlled with OADs ± BI/GLP‐1 RAs (Colombia and Mexico) improved glycaemic control, with reductions in HbA1c, FPG and PPG levels over the study period. Once‐daily iGlarLixi can potentially be an effective and safe therapeutic option in this population.
Author Contributions
J.M.A.‐D. was part of the steering committee of the global study. J.M.A.‐D., J.L.T.‐G. and L.S.‐R. were involved in recruiting participants to the study. All authors were involved in the conceptualisation of the present manuscript. All authors were involved in drafting the work or revising it critically for important intellectual content, and in the final approval of the version to be published. All authors have agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding
This study was funded by Sanofi, Paris, France.
Conflicts of Interest
J.M.A.‐D. has received honorarium for talks in the setting of medical education and for participation in advisory boards from Sanofi, Novo Nordisk, Astra Zeneca, and Eli Lilly. J.L.T.‐G. has received honorarium for talks in the setting of medical education from Sanofi, Novo Nordisk, Abbott Nutrition, Boehringer Ingelheim, Astra Zeneca, Pfizer, Bayer and Aspen. L.S.‐R. has acted as an adviser and speaker for Novo Nordisk, Sanofi and Boehringer Ingelheim. C.S.‐C. and L.A.‐M. are Sanofi employees and may hold stock and/or stock options from the company.
Supporting information
Table S1: Secondary endpoints.
Table S2: Number of hypoglycaemia events and event rates PPY per type of hypoglycaemia during the study period (safety population).
Table S3: Number (%) of participants with AEs by primary system organ class and preferred term during the study period (safety population).
Figure S1: Study design.
Figure S2: Participant disposition.
Figure S3: (A) Change in FPG level (mg/dL) from baseline to Month 12 (eligible population) and (B) change in PPG level (mg/dL) from baseline to Month 12 (eligible population).
Figure S4: Change in body weight (kg) from baseline (eligible population).
Figure S5: iGlarLixi daily dose (insulin glargine [U]) change from baseline (safety population).
Figure S6: Mean TRIM‐D scores (eligible population).
Figure S7: (A) Patient‐reported and (B) physician‐reported Global Treatment Effectiveness Evaluation scores (eligible population).
Acknowledgements
The authors are grateful to all the study participants, and they would like to thank all the trial staff and investigators who participated in the data collection for the study. Manuscript writing support was provided by Anuja Vaidya, MPharm; Suvranil Mitra, MSc; and Umakant Bahirat, PhD, employees of Sanofi.
Arteaga‐Diaz J. M., Torres‐Grajales J. L., Sauque‐Reyna L., Salamanca‐Carrillo C., and Anguiano‐Medrano L., “Real‐World Effectiveness and Safety of iGlarLixi in People With Type 2 Diabetes in LATAM Region: A Subanalysis of the SUCCESS Study,” Diabetes, Obesity and Metabolism 28, no. 9 (2026): 8724–8728, 10.1111/dom.71018.
Handling Editor: Richard Donnelly
Data Availability Statement
Qualified researchers may request access to patient‐level data and related documents. Patient‐level data will be anonymised, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies and process for requesting access can be found at https://www.vivli.org.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1: Secondary endpoints.
Table S2: Number of hypoglycaemia events and event rates PPY per type of hypoglycaemia during the study period (safety population).
Table S3: Number (%) of participants with AEs by primary system organ class and preferred term during the study period (safety population).
Figure S1: Study design.
Figure S2: Participant disposition.
Figure S3: (A) Change in FPG level (mg/dL) from baseline to Month 12 (eligible population) and (B) change in PPG level (mg/dL) from baseline to Month 12 (eligible population).
Figure S4: Change in body weight (kg) from baseline (eligible population).
Figure S5: iGlarLixi daily dose (insulin glargine [U]) change from baseline (safety population).
Figure S6: Mean TRIM‐D scores (eligible population).
Figure S7: (A) Patient‐reported and (B) physician‐reported Global Treatment Effectiveness Evaluation scores (eligible population).
Data Availability Statement
Qualified researchers may request access to patient‐level data and related documents. Patient‐level data will be anonymised, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies and process for requesting access can be found at https://www.vivli.org.