Efficacy and safety of insulin degludec/aspart in patients with type 2 and type 1 diabetes mellitus: real-world evidence from Indonesia.
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| Název: | Efficacy and safety of insulin degludec/aspart in patients with type 2 and type 1 diabetes mellitus: real-world evidence from Indonesia. |
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| Autoři: | Zufry H; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia.; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.; Innovation and Research Center of Endocrinology, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia., Sucipto KW; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia.; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.; Innovation and Research Center of Endocrinology, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia., Ekadamayanti AS; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia.; Division of Endocrinology, Metabolism and Diabetes-Thyroid Center, Department of Internal Medicine, Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.; Innovation and Research Center of Endocrinology, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia., Iqbal Q; Innovation and Research Center of Endocrinology, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia. |
| Zdroj: | Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2025 Nov 10; Vol. 16, pp. 1690169. Date of Electronic Publication: 2025 Nov 10 (Print Publication: 2025). |
| Způsob vydávání: | Journal Article |
| Jazyk: | English |
| Informace o časopise: | Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101555782 Publication Model: eCollection Cited Medium: Print ISSN: 1664-2392 (Print) Linking ISSN: 16642392 NLM ISO Abbreviation: Front Endocrinol (Lausanne) Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [Lausanne : Frontiers Research Foundation] |
| Výrazy ze slovníku MeSH: | Diabetes Mellitus, Type 2*/drug therapy , Diabetes Mellitus, Type 2*/blood , Diabetes Mellitus, Type 2*/epidemiology , Diabetes Mellitus, Type 1*/drug therapy , Diabetes Mellitus, Type 1*/blood , Diabetes Mellitus, Type 1*/epidemiology , Insulin, Long-Acting*/therapeutic use , Insulin, Long-Acting*/adverse effects , Hypoglycemic Agents*/therapeutic use , Hypoglycemic Agents*/adverse effects, Humans ; Female ; Indonesia/epidemiology ; Male ; Adult ; Middle Aged ; Blood Glucose/analysis ; Prospective Studies ; Glycated Hemoglobin/analysis ; Treatment Outcome ; Drug Combinations ; Hypoglycemia/chemically induced ; Hypoglycemia/epidemiology |
| Abstrakt: | Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Background: Real-world studies on insulin degludec/aspart (IDegAsp) have been conducted in some Southeast Asian populations; however, data specific to Indonesia remain limited. The aim of this study was to evaluate the efficacy, safety profiles, and real-world clinical experience of IDegAsp after five years of implementation in diabetes care in Indonesia. Methods: This five-year, single-center, open-label, prospective, non-interventional study included adults with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) who had been on IDegAsp treatment for at least 12 months. Glycemic and metabolic outcomes-glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), and body mass index (BMI)-were assessed at baseline, 3, 6, and 12 months. The safety was evaluated based on hypoglycemia incidence. Clinical rationale for IDegAsp initiation and regimen models were also documented. Results: A total of 550 individuals (T1DM: 48; T2DM: 502) were included. At 12 months, both groups had significant reductions in HbA1c (T1DM: -3.60%, T2DM: -3.32%), FPG (T1DM: -119.39 mg/dL, T2DM: -105.60 mg/dL), and PPG (T1DM: -190.87 mg/dL, T2DM: -180.10 mg/dL) (all p < 0.001 compared to baseline). Slight but statistically significant increases in BMI were observed in both groups (both p < 0.001). No episodes of hypoglycemia were reported among T1DM patients, whereas in the T2DM cohort, it occurred in 3.0% of cases comprising 1.4% with a single episode and 1.6% with two episodes with no severe hypoglycemia reported. The most frequent reasons for initiating IDegAsp included suboptimal HbA1c and PPG levels, with T2DM patients more often citing the need for flexible injection time or schedule. Conclusion: IDegAsp demonstrated sustained glycemic improvement at 3-, 6-, and 12-months follow-ups with a favorable safety profile over one year, in both T1DM and T2DM populations in Indonesia. These findings support its utility in routine clinical practice, particularly among patients with unmet glycemic targets or complex treatment needs. (Copyright © 2025 Zufry, Sucipto, Ekadamayanti and Iqbal.) |
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| Contributed Indexing: | Keywords: IDegAsp; Indonesia; diabetes; insulin degludec/aspart; real-world data |
| Substance Nomenclature: | 0 (Insulin, Long-Acting) 0 (Hypoglycemic Agents) 0 (Blood Glucose) 0 (Glycated Hemoglobin) 0 (Drug Combinations) 0 (insulin degludec, insulin aspart drug combination) 0 (hemoglobin A1c protein, human) |
| Entry Date(s): | Date Created: 20251126 Date Completed: 20251126 Latest Revision: 20251128 |
| Update Code: | 20251128 |
| PubMed Central ID: | PMC12640829 |
| DOI: | 10.3389/fendo.2025.1690169 |
| PMID: | 41293743 |
| Databáze: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.<br />Background: Real-world studies on insulin degludec/aspart (IDegAsp) have been conducted in some Southeast Asian populations; however, data specific to Indonesia remain limited. The aim of this study was to evaluate the efficacy, safety profiles, and real-world clinical experience of IDegAsp after five years of implementation in diabetes care in Indonesia.<br />Methods: This five-year, single-center, open-label, prospective, non-interventional study included adults with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) who had been on IDegAsp treatment for at least 12 months. Glycemic and metabolic outcomes-glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), and body mass index (BMI)-were assessed at baseline, 3, 6, and 12 months. The safety was evaluated based on hypoglycemia incidence. Clinical rationale for IDegAsp initiation and regimen models were also documented.<br />Results: A total of 550 individuals (T1DM: 48; T2DM: 502) were included. At 12 months, both groups had significant reductions in HbA1c (T1DM: -3.60%, T2DM: -3.32%), FPG (T1DM: -119.39 mg/dL, T2DM: -105.60 mg/dL), and PPG (T1DM: -190.87 mg/dL, T2DM: -180.10 mg/dL) (all p < 0.001 compared to baseline). Slight but statistically significant increases in BMI were observed in both groups (both p < 0.001). No episodes of hypoglycemia were reported among T1DM patients, whereas in the T2DM cohort, it occurred in 3.0% of cases comprising 1.4% with a single episode and 1.6% with two episodes with no severe hypoglycemia reported. The most frequent reasons for initiating IDegAsp included suboptimal HbA1c and PPG levels, with T2DM patients more often citing the need for flexible injection time or schedule.<br />Conclusion: IDegAsp demonstrated sustained glycemic improvement at 3-, 6-, and 12-months follow-ups with a favorable safety profile over one year, in both T1DM and T2DM populations in Indonesia. These findings support its utility in routine clinical practice, particularly among patients with unmet glycemic targets or complex treatment needs.<br /> (Copyright © 2025 Zufry, Sucipto, Ekadamayanti and Iqbal.) |
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| ISSN: | 1664-2392 |
| DOI: | 10.3389/fendo.2025.1690169 |