Exploring early combination strategy in Latin American patients with newly diagnosed type 2 diabetes: a sub-analysis of the VERIFY study
Open Access
- 15 June 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in Diabetology & Metabolic Syndrome
- Vol. 13 (1), 1-13
- https://doi.org/10.1186/s13098-021-00686-9
Abstract
Background: Patients with type 2 diabetes mellitus (T2DM) from Latin American countries face challenges in access to healthcare, leading to under-diagnosis, under-achievement of glycemic target, and long-term complications. Early diagnosis and treatment initiation are of paramount importance in this population due to the high prevalence of risk factors such as obesity and metabolic syndrome. The VERIFY study in patients with newly diagnosed T2DM (across 34 countries), assessed the normoglycemic durability (5 years), with early combination (EC) therapy approach versus the traditional stepwise approach of initiating treatment with metformin monotherapy (MET). Here we present the results from the VERIFY study for participants from eight countries in Latin America. Methods: Newly diagnosed adult patients with T2DM, HbA1c 6.5–7.5% and body-mass index (BMI) of 22–40 kg/m2 were enrolled. The primary endpoint was time to initial treatment failure (TF; HbA1c ≥ 7.0% at two consecutive scheduled visits 13 weeks apart). Time to second TF was evaluated when patients in both groups were receiving and failing on the vildagliptin combination. Safety and tolerability were also assessed for both treatment approaches during the study. Results: A total of 537 eligible patients (female, 58.8%) were randomly assigned to receive either EC (n = 266) or MET (n = 271). EC significantly reduced the relative risk of time to initial TF by 47% versus MET [HR (95% CI) 0.53 (0.4, 0.7) p < 0.0001]. Overall, 46.4% versus 66.3% of patients achieved the primary endpoint in the EC and MET groups, with a median [interquartile range (IQR)] time to TF of 59.8 (27.5, not evaluable) and 33.4 (12.2, 60.1) months, respectively. The risk for time to second TF was 31% lower with EC (p < 0.0092). A higher proportion of patients receiving EC maintained durable HbA1c < 7.0%, < 6.5%, and < 6.0%. Both treatment approaches were well tolerated, and only 3.2% of participants discontinued the study due to adverse events. All hypoglycemic events (EC: n = 7 and MET: n = 3) were single, mild episodes and did not lead to study discontinuation. Conclusion: Similar to the global population, long-term clinical benefits were achieved more frequently and without tolerability issues with EC versus standard-of-care MET in this Latin American sub-population. This study is registered with ClinicalTrials.gov, NCT01528254.Keywords
Funding Information
- Novartis Pharma AG
This publication has 31 references indexed in Scilit:
- Study to determine the durability of glycaemic control with early treatment with a vildagliptin–metformin combination regimen vs. standard‐of‐care metformin monotherapy—the VERIFY trial: a randomized double‐blind trialDiabetic Medicine, 2014
- Comparative effectiveness of vildagliptin in combination with other oral anti-diabetes agents in usual-care conditions: the EDGE–Latin America studyCurrent Medical Research and Opinion, 2014
- Diabetes in South and Central America: An updateDiabetes Research and Clinical Practice, 2014
- Long-Term Safety, Tolerability, and Weight Loss Associated With Metformin in the Diabetes Prevention Program Outcomes StudyDiabetes Care, 2012
- Treatment of type 2 diabetes in Latin America: a consensus statement by the medical associations of 17 Latin American countriesRevista Panamericana de Salud Pública, 2010
- Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment‐naive patients with type 2 diabetes mellitusDiabetes, Obesity and Metabolism, 2009
- 10-Year Follow-up of Intensive Glucose Control in Type 2 DiabetesThe New England Journal of Medicine, 2008
- Exclusion of Women From Clinical Research: Myth or Reality?Mayo Clinic Proceedings, 2008
- Exclusion of Women From Clinical Research: Myth or Reality?Mayo Clinic Proceedings, 2008
- The Economic Development of Latin America in the Twentieth CenturyEconomic Geography, 2001