Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses
調査の概要
状態
条件
詳細な説明
The CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA) is an ongoing randomized controlled trial (RCT) designed to assess whether linagliptin is non-inferior, and if so, superior compared with glimepiride 1-4 mg once daily with respect to cardiovascular (CV) events in adults with relatively early Type 2 Diabetes at increased risk of CV events and with less than optimized glycaemic control. Given that medications of both classes are currently advocated as second-line therapy after metformin, and since sulfonylureas have been associated with concerns regarding their CV safety, while dipeptidyl peptidase-4 inhibitors have been suggested to exhibit CV benefits in preclinical and mechanistic trials, the results of this trial will provide answers to several clinically relevant questions and have a significant impact on clinical practice.
This cohort study was initiated to predict the findings of CAROLINA trial in a real world setting using electronic claims data from insurance databases with results anticipated prior to the completion of CAROLINA. Trial eligibility criteria were adapted in claims data to generate a comparable study cohort (of linagliptin and glimepiride initiators) to that of the trial population. Using 1:1 propensity score-matching was used to control for >120 baseline characteristics. Patients were followed up for a composite cardiovascular outcome adapted from the primary end-point of the CAROLINA trial.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02120
- Brigham and Women's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Patients with Type 2 diabetes who were new users of Linagliptin or new users of Glimepiride and:
- Had no more than 3 anti-diabetic drugs including index drug
AND at elevated risk of cardiovascular (CV) events according to specific criteria:
- Previous vascular disease
- Evidence of vascular-related end-organ damage
- Age ⩾ 70 years
⩾ 2 CV risk factors:
- Treated hypertension
- Smoking
- Using any lipid lowering treatment
- Age ≥ 40 and ≤ 85 years at treatment initiation
Exclusion Criteria:
- Patients with Type 1 Diabetes Mellitus
- Previous exposure to dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, thiazolidinediones (TZDs), insulin or sodium glucose co-transporter-2 (SGLT-2s).
- Exclude anti-diabetic background therapy if initiated in 2 months prior
- Morbid obesity or treatment with anti-obesity drugs 3 months prior to treatment initiation
- Severe hyperglycemia
- Active liver disease or impaired hepatic function
- Any previous bariatric surgery
- Coronary artery re-vascularisation ≤ 6 weeks prior to treatment initiation
- Prior hospitalization for congestive heart failure
- Acute or chronic metabolic acidosis
- Hereditary galactose intolerance
- Alcohol or drug abuse within the 3 months prior to treatment initiation
- Use of oral corticosteroids
- Pregnant women
- Patients with cancer
- Acute coronary syndrome ≤ 6 weeks prior to treatment initiation
- Stroke or Transient ischemic attack ≤ 3 months prior to treatment initiation
研究計画
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 |
|---|
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Linagliptin
Patients who initiate Linagliptin with no use in the prior 180 days
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Glimepiride
Patients who initiate Glimepiride with no use in the prior 180 days
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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 |
|---|---|---|
|
Composite Cardiovascular (CV) Outcome
時間枠：From treatment initiation to end of follow-up, up to 53 months
|
Composite CV Outcome includes Myocardial infarction, Stroke, hospitalization for unstable angina and Death
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From treatment initiation to end of follow-up, up to 53 months
|
協力者と研究者
捜査官
- 主任研究者：Elisabetta Patorno, MD DrPH、Brigham and Women's Hospital, Harvard Medical School
出版物と役立つリンク
一般刊行物
- Franklin JM, Patorno E, Desai RJ, Glynn RJ, Martin D, Quinto K, Pawar A, Bessette LG, Lee H, Garry EM, Gautam N, Schneeweiss S. Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative. Circulation. 2021 Mar 9;143(10):1002-1013. doi: 10.1161/CIRCULATIONAHA.120.051718. Epub 2020 Dec 17.
- Patorno E, Schneeweiss S, Gopalakrishnan C, Martin D, Franklin JM. Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial: Cardiovascular Safety of Linagliptin Versus Glimepiride. Diabetes Care. 2019 Dec;42(12):2204-2210. doi: 10.2337/dc19-0069. Epub 2019 Jun 25.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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