Young-Hwan Park; Minji Sohn; Soo Lim

doi:10.4093/dmj.2024.0485

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Response Two-Year Therapeutic Efficacy and Safety of Initial Triple Combination of Metformin, Sitagliptin, and Empagliflozin in Drug-Naïve Type 2 Diabetes Mellitus Patients (Diabetes Metab J 2024;48:253-64): Young-Hwan Park, Minji Sohn, Soo Lim; Diabetes & Metabolism Journal 2024;48(5):1012-1013.
DOI: https://doi.org/10.4093/dmj.2024.0485
Published online: September 12, 2024

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Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea

Corresponding author: Soo Lim

Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea E-mail: limsoo@snu.ac.kr

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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See the letter "Two-Year Therapeutic Efficacy and Safety of Initial Triple Combination of Metformin, Sitagliptin, and Empagliflozin in Drug-Naïve Type 2 Diabetes Mellitus Patients (Diabetes Metab J 2024;48:253-64)" on page 1005.

We extend our gratitude to the reviewer for her thoughtful and insightful comments on our research and its broader implications [1]. We also concur with Professor Lee’s perspective that triple combination therapy with metformin, sitagliptin, and empagliflozin represents a promising strategy for drug-naïve patients with type 2 diabetes mellitus. The current body of evidence indicates that this initial triple combination therapy yields more durable reductions in glycosylated hemoglobin (HbA1c) compared to therapies that solely lower glucose levels without addressing the underlying metabolic abnormalities. Furthermore, the treatment provides superior glycemic control relative to monotherapy or a stepwise approach, and it enhances insulin sensitivity and β-cell function in patients with newly diagnosed type 2 diabetes mellitus [1-5].

Additionally, we would like to take this opportunity to provide a detailed commentary on the use of insulin in our study. Insulin therapy was administered to six of 36 patients whose HbA1c level remained at or above 7.0% after 24 months. Notably, in these six patients, HbA1c level was not well-controlled, with values of 12.9%±1.6% at baseline, 9.0%±1.4% at 12 months, and 11.1%±2.3% at 24 months. Despite these elevated HbA1c level, these patients did not exhibit hyperglycemic symptoms such as polyuria, polydypsia, or weight loss. For example, body weight increased over the treatment period: 72.6±30.4 kg at baseline, 74.5±33.4 kg at 12 months, and 77.8±34.0 kg at 24 months. Conversely, for the 30 patients who did not require insulin therapy, HbA1c level was relatively well-controlled (10.6%±1.6% at baseline, 7.2%±0.8% at 12 months, and 8.0%±1.1% at 24 months). They also did not present hyperglycemic symptoms, with stable weight (73.4±17.3 kg at baseline, 72.0±16.4 kg at 12 months, and 73.4±15.4 kg at 24 months) and no reports of polydipsia or polyuria.

We acknowledge the limitations of our study, as highlighted by our colleagues. Our research lacks a comparative arm with traditional sequential therapy or other combination therapies, and the potential for bias in subgroup analyses cannot be fully excluded. Additionally, the study population consisted exclusively of Korean patients from a single hospital, which may limit the generalizability of our findings. Nevertheless, there is a growing consensus on the superiority of triple combination therapy over stepwise therapy for achieving long-term durable glycemic control [2-5]. To solidify the role of this initial triple combination therapy as a viable strategy for drug-naïve patients with type 2 diabetes mellitus, we hope that future large-scale prospective studies will further validate the long-term efficacy and safety of this approach.

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CONFLICTS OF INTEREST

No potential conflict of interest relevant to this article was reported.

REFERENCES

1. Park YH, Sohn M, Lee SY, Lim S. Two-year therapeutic efficacy and safety of initial triple combination of metformin, sitagliptin, and empagliflozin in drug-naïve type 2 diabetes mellitus patients. Diabetes Metab J 2024;48:253-64.PubMed PMC
2. Lim S, Ku EJ, Lee SY, Lee JH, Lee JE, Kim KM, et al. Therapeutic efficacy and safety of initial triple combination of metformin, sitagliptin, and lobeglitazone in drug-naïve patients with type 2 diabetes: initial triple study. BMJ Open Diabetes Res Care 2020;8:e000807.Article PubMed PMC
3. Abdul-Ghani M, Puckett C, Adams J, Khattab A, Baskoy G, Cersosimo E, et al. Durability of triple combination therapy versus stepwise addition therapy in patients with new-onset T2DM: 3-year follow-up of EDICT. Diabetes Care 2021;44:433-9.Article PubMed PDF
4. Abdul-Ghani MA, Puckett C, Triplitt C, Maggs D, Adams J, Cersosimo E, et al. Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the efficacy and durability of initial combination therapy for type 2 diabetes (EDICT): a randomized trial. Diabetes Obes Metab 2015;17:268-75.PubMed PMC
5. Kim NH, Moon JS, Lee YH, Cho HC, Kwak SH, Lim S, et al. Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add-on therapy in drug-naïve patients with type 2 diabetes (TRIPLE-AXEL study): a multicentre, randomized, 104-week, open-label, active-controlled trial. Diabetes Obes Metab 2024;26:3642-52.PubMed

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Two-Year Therapeutic Efficacy and Safety of Initial Triple Combination of Metformin, Sitagliptin, and Empagliflozin in Drug-Naïve Type 2 Diabetes Mellitus Patients (Diabetes Metab J 2024;48:253-64)

Diabetes Metab J. 2024;48(5):1012-1013. Published online September 12, 2024

DOI: https://doi.org/10.4093/dmj.2024.0485

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Park YH, Sohn M, Lim S. Two-Year Therapeutic Efficacy and Safety of Initial Triple Combination of Metformin, Sitagliptin, and Empagliflozin in Drug-Naïve Type 2 Diabetes Mellitus Patients (Diabetes Metab J 2024;48:253-64). Diabetes Metab J. 2024;48(5):1012-1013.

DOI: https://doi.org/10.4093/dmj.2024.0485.

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