Study of Adult Patients Residing in Argentina Diagnosed With Type 2 Diabetes Treated With a New Formulation of Semaglutide, Both Oral and Subcutaneous, in a Real-world Setting at 3 Months, 6 Months, and 1 Year of Follow-up, Quantifying the Reduction in Glycated Hemoglobin (SEMA-REAL ARG)
2026年6月1日 更新者：Ivan A. Huespe、Hospital Italiano de Buenos Aires
New Formulation of Semaglutide in the Treatment of Type 2 Diabetes in Argentina: a Prospective, Multicenter, Real-world Study
The goal of this prospective, multicenter, observational study is to evaluate the real-world effectiveness and safety of oral and subcutaneous semaglutide in adults with type 2 diabetes mellitus in Argentina. The main objective is to assess changes in glycated hemoglobin (HbA1c) from baseline to 3, 6, and 12 months after treatment initiation. Secondary objectives include evaluating changes in body weight, waist circumference, hand-grip strength, treatment satisfaction, medication adherence, treatment route switching, treatment discontinuation, and adverse events.
Participants will receive semaglutide as prescribed by their treating physician as part of routine clinical care. Follow-up assessments will be performed at 3, 6, and 12 months to collect clinical, laboratory, safety, treatment satisfaction, and adherence data. Treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and adherence will be assessed using the Simplified Medication Adherence Questionnaire (SMAQ).
調査の概要
研究の種類
観察的
入学 (推定)
145
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Martín L Gil Folgar, MD
- 電話番号：+5411 1520497361
- メール：martin.gilfolgar@hospitalitaliano.org.ar
研究連絡先のバックアップ
- 名前：Natalia Nachón, MD
- 電話番号：+54 9 11 155876-3407
- メール：dra.nachon@gmail.com
研究場所
-
-
Buenos Aires
-
Buenos Aires、Buenos Aires、アルゼンチン、1199
- 募集
- Hospital Italiano de Buenos Aires
-
コンタクト：
- Martín L Gil Folgar, MD
- 電話番号：+5411 1520497361
- メール：martin.gilfolgar@hospitalitaliano.org.ar
-
Buenos Aires、Buenos Aires、アルゼンチン、1427
- 募集
- Hospital General de Agudos Dr Enrique Tornú
-
コンタクト：
- María N Nachón, MD
- 電話番号：+54 9 11 155876-3407
- メール：dra.nachon@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Study participants will be selected from adult patients with type 2 diabetes receiving routine medical care at outpatient endocrinology and internal medicine clinics across multiple centers in Argentina.
説明
Inclusion Criteria:
- Age ≥ 18 years.
- Clinical diagnosis of type 2 diabetes mellitus.
- Baseline glycated hemoglobin (HbA1c) >7% and ≤12%.
- Initiating treatment with semaglutide (oral or subcutaneous) prescribed by the treating physician according to clinical judgment.
Exclusion Criteria:
- Pregnancy or lactation at the time of enrollment.
- History of severe hypersensitivity or adverse reactions to glucagon-like peptide-1 (GLP-1) receptor agonists.
- Contraindications to semaglutide as listed in the product label (e.g., severe gastrointestinal disease, certain endocrine tumors).
- Any other serious medical condition that, in the investigator's opinion, may interfere with study participation or data interpretation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients with Type 2 Diabetes Treated with Semaglutide (Oral or Subcutaneous)
This cohort includes adults aged 18 years or older with type 2 diabetes mellitus who initiate treatment with oral or subcutaneous semaglutide as prescribed by their treating physician in routine clinical practice.
The study is observational and does not assign treatment.
Dose, formulation, and route of administration are determined by the treating physician according to standard care.
|
Participants will receive semaglutide as part of their usual medical care for type 2 diabetes mellitus.
The intervention of interest includes both oral and subcutaneous formulations of semaglutide, prescribed and dosed at the discretion of the treating physician according to routine clinical practice.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Mean change in HbA1c (%) compared with baseline among adult patients with type 2 diabetes treated with oral or subcutaneous semaglutide in real-world clinical practice.
|
Baseline, 3 months, 6 months, and 12 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Weight
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Mean change in body weight (kg) compared with baseline.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Change in Waist Circumference
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Mean change in waist circumference (cm) compared with baseline.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Change in Hand-Grip Strength
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Mean change in grip strength (kg) measured with a hand dynamometer.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Change from baseline in treatment satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire.
The total treatment satisfaction score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Proportion of participants classified as adherent according to the Simplified Medication Adherence Questionnaire.
Participants will be classified as adherent or non-adherent according to the questionnaire scoring rules.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Proportion of Patients Switching Administration Route
時間枠：Up to 12 months.
|
Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.
|
Up to 12 months.
|
|
Reasons for Treatment Discontinuation
時間枠：Up to 12 months.
|
Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).
|
Up to 12 months.
|
|
Adverse Events
時間枠：Up to 12 months.
|
Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.
|
Up to 12 months.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Semaglutide Dose Over Time
時間枠：Baseline, 3 months, 6 months, and 12 months.
|
Evaluation of dose adjustments (increases or reductions) across follow-up visits.
|
Baseline, 3 months, 6 months, and 12 months.
|
|
Subgroup Analysis by Administration Route
時間枠：Up to 12 months.
|
Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.
|
Up to 12 months.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：María Natalia Nachón, MD、Hospital General de Agudos Dr Enrique Tornú
- スタディディレクター：Iván A Huespe, MD、Hospital Italiano de Buenos Aires
- スタディチェア：Matías Mirofsky, MD、Hospital Leónidas Lucero, Bahía Blanca
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Knobel H, Alonso J, Casado JL, Collazos J, Gonzalez J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. doi: 10.1097/00002030-200203080-00012.
- Rojas-Roque C, Hernandez-Vasquez A, Azanedo D, Bendezu-Quispe G. Socioeconomic Inequalities in the Prevalence of Diabetes in Argentina: A Repeated Cross-Sectional Study in Urban Women and Men. Int J Environ Res Public Health. 2022 Jul 22;19(15):8888. doi: 10.3390/ijerph19158888.
- Burgos MA, Morales Mendez EJ, Russo MP, Martingano I, Lopez Gutierrez MP, Maccio AM, Segalini A, Plazzotta F, Otero C, Orrego N, Grande Ratti MF. Utilizing Secondary Data from Electronic Health Records for Automated Frailty Detection in Older Adults with Diabetes. Stud Health Technol Inform. 2025 Aug 7;329:179-183. doi: 10.3233/SHTI250825.
- American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S181-S206. doi: 10.2337/dc25-S009.
- Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.
- Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzik M; PIONEER 1 Investigators. PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Diabetes Care. 2019 Sep;42(9):1724-1732. doi: 10.2337/dc19-0749. Epub 2019 Jun 11.
- Mahapatra MK, Karuppasamy M, Sahoo BM. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes. Rev Endocr Metab Disord. 2022 Jun;23(3):521-539. doi: 10.1007/s11154-021-09699-1. Epub 2022 Jan 7.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年8月4日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 15820
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
The study involves observational data collected from real-world clinical practice under strict confidentiality agreements and in compliance with Argentine data protection laws (Law 25.326).
Individual participant data will remain anonymized and securely stored in the REDCap database accessible only to authorized investigators.
Aggregate and de-identified results may be shared through scientific publications and conference presentations, but individual-level data will not be made publicly available to protect patient privacy.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。