Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)
Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Moscow、ロシア連邦
- Research Site
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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
Data of T2DM patients consecutively included in the RNDR from January 2015 to October 2017 will be included in this retrospective analysis. New users will be defined as individuals with T2DM either receiving a prescription of a SGLT-2 inhibitor or other GLD during the study period. Individuals with a previous issued/dispensed prescription of that medicine class during the preceding 1 year are not defined as new users. The year of the first issued prescription of the included medication classes during the study period will be denoted the index year. The group of other GLD will include all diabetes medicines, allowing combinations and monotherapy use except use of SGLT-2 inhibitors. The class SGLT-2 inhibitors include mainly dapagliflozin, empagliflozin and canagliflozin.
Since SGLT-2 inhibitors are relatively recently introduced on the market the population size and follow-up time is limited. Approximately 22,000 patients registered in RNDR will be included.
説明
Inclusion criteria are:
- New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups;
- T2DM diagnosis on or prior to the index year;
- ≥ 18 years old at index year.
Exclusion criteria are:
- Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index;
- Patients with a gestational diabetes in the index year or 1 year prior to index.
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
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 |
---|---|---|
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017
時間枠:2015-2017
|
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016 2017 among T2DM patients initiated use of antidiabetic treatment in these years according to Russian National Diabetes Registry data.
|
2015-2017
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of participants with abdominal laboratory values
時間枠:2015-2017
|
Number of participants with abdominal laboratory values glycosylated haemoglobin (Hb1Ac), total Cholesterol, low Density Lipids (LDL), high Density Lipids (HDL), creatinine, estimated Glomerular Filtration Rate (EGFR)
|
2015-2017
|
Number of participants with co-morbidities
時間枠:2015-2017
|
Number of participants with co-morbidities: myocardial infarction (MI), stroke (ischemic or hemorrhagic )Transient Ischemic Attack (TIA)Peripheral Artery Disease (PAD), Heart Failure, Hypertension, Hyperlipidemia, Neuropathy, Nephropathy, Retinopathy, Therapies, Diabetes medications, Hypertension medications, Diuretics, Lipid lowering drugs, Anti-platelets.
|
2015-2017
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
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
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。
2型糖尿病の臨床試験
-
Centre Hospitalier Universitaire, Amiens募集
-
Jin-Hee AhnAsan Medical CenterわからないHER-2遺伝子増幅 | HER-2 タンパク質の過剰発現
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.募集
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.まだ募集していませんSARS-CoV-2
-
AIM Vaccine Co., Ltd.まだ募集していません
-
Ridgeback Biotherapeutics, LPMerck Sharp & Dohme LLC完了
-
Peking UniversityCenters for Disease Control and Prevention, China; Beijing Pinggu District Hospital; Peking University...完了