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治験 NCT05220917 (CER-4-T2D)（対象：心血管イベント、2型糖尿病、腎疾患）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ブリガム・アンド・ウィメンズ病院Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (CER-4-T2D) 781,430 直接比較 観察研究
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05220917 (CER-4-T2D) は 観察研究 臨床試験 で、心血管イベント、2型糖尿病、腎疾患 に関するものです。現在は 実施中／登録終了 で、2021年8月1日 から開始しています。781,430 名の参加者 の募集が計画されています。この試験は ブリガム・アンド・ウィメンズ病院 によって主導され、2026年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月8日 です。
概要
To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in he...もっと見る
詳細説明
Aim 1: (1a.) To evaluate the effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons with respect to cardiovascular (CV) events, mortality, renal events, and other patient-centered outcomes (e.g., time spent at home),...もっと見る
公式タイトル
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
疾患名
心血管イベント2型糖尿病腎疾患その他の研究識別子
- CER-4-T2D
- 2021P001784
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
SGLT-2i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
DPP-4i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | GLP-1RA Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
SU (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
GLP-1 RA (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | GLP-1RA Any SGLT2i dispensing claim |
SU (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
DPP-4i (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
MACE | Myocardial Infarction, Ischemic Stroke, Cardiovascular mortality | through study completion, an average of 1 year |
Modified MACE | Myocardial Infarction, Ischemic Stroke, All-Cause mortality | through study completion, an average of 1 year |
Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF) | through study completion, an average of 1 year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Myocardial Infarction (MI) | through study completion, an average of 1 year | |
Stroke | through study completion, an average of 1 year | |
Cardiovascular Mortality | through study completion, an average of 1 year | |
All-cause mortality | through study completion, an average of 1 year | |
Coronary revascularization | through study completion, an average of 1 year |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry
- At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry
- Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry
- Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry *
- Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry
- Missing age or gender information
- Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD)
- Diagnosis of type 1 diabetes within 12 months before and including cohort entry
- Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry
- Any insulin fill or prescription within 12 months before and including cohort entry
- Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry
- Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry
- Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry
- Diagnosis of MEN-2 within 12 months before and including cohort entry
- Recorded solid organ transplant code within 12 months before and including cohort entry
- Patients with recorded initiation of more than one agent within a comparator class at cohort entry
ブリガム・アンド・ウィメンズ病院398 件のアクティブな治験を探索責任者
Elisabetta Patorno, 主任研究者, Associate Professor of Medicine, Brigham and Women's Hospital
連絡先情報がありません。
1 1カ国の場所
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States