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Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes 第IV相・フェーズ4 186 個別化医療

状況不明
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治験番号 NCT03377335 は 2型糖尿病 に関する 治療 の研究で、第IV相・フェーズ4 介入研究 臨床試験 です。現在は 状況不明 で、2017年12月22日 から開始しています。186 名の参加者 の募集が計画されています。この試験は University of Palermo によって主導され、2019年1月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2018年2月26日 です。
概要
Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class antidiabetes agents which produces significant and sustained reductions in glycemic parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are still largely unknown.

The investigators will evaluate for the first time the effect of dapagliflozin on multiple cardio-metabolic risk markers in one study....

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詳細説明
The investigators will perform an open label, two-arms, prospective intervention study using dapagliflozin+metformin vs. metformin alone for a period of 6 months in patients with T2DM.

The research hypothesis is to assess whether dapagliflozin can improve cardio-metabolic outcome, reducing subclinical atherosclerosis, endothelial dysfunction and different cardio-metabolic markers (including inflammatory markers, cyt...

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公式タイトル

Effect of Dapagliflozin on Cardio-Metabolic Risk Factors in Patients With Type-2 Diabetes

疾患名
2型糖尿病
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • ESR-16-12388
NCT番号
NCT03377335
開始日
2017-12-22
最終更新日
2018-02-26
終了予定日
2019-01
目標参加者数
186
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
状況不明
キーワード
Dapagliflozin
Type 2 diabetes mellitus
Carotid intima-media thickness
Endothelial dysfunction
Atherogenic lipoproteins
Inflammatory markers
microRNAs
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Dapagliflozin
Dapagliflozin (10mg daily) as add-on to metformin (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.
Dapagliflozin 10mg
The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: \>87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.
プラセボ対照薬Metformin alone
Metformin alone (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.
メトホルミン
All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: \>87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.
主要評価項目
評価指標指標の説明時間枠
Subclinical atherosclerosis
To assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT).
Change from baseline to 6 months of the treatment
副次評価項目
評価指標指標の説明時間枠
Endothelial dysfunction
To assess the effects of dapagliflozin on endothelial dysfunction through the evaluation of flow mediated dilation (FMD) of the brachial artery.
Change from baseline to 6 months of the treatment
Oxidative stress
To assess the effects of dapagliflozin on oxidative stress including plasma glutathione, serum lipid hydroperoxides and reactive oxygen species.
Change from baseline to 6 months of the treatment
Atherogenic lipoproteins
To assess the effects of dapagliflozin on atherogenic lipoproteins including the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.
Change from baseline to 6 months of the treatment
Inflammatory markers
To assess the effects of dapagliflozin on inflammatory markers, including plasma cytokines (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.
Change from baseline to 6 months of the treatment
microRNAs
To assess the effects of dapagliflozin on microRNAs. The miRNAs are endogenous 21-25 nucleotides noncoding RNA, and they are regulators of gene expression that post transcriptionally modify cellular responses and function. The miRNAs will be isolated from sera using the mirVana miRNA Isolation Kit (Ambion, Waltham, MA, USA), and then quantified by SYBR Green Real-Time (RT) polymerase chain reaction (PCR).
Change from baseline to 6 months of the treatment
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
19 Years
対象性別
全て
  • men and women with T2DM;
  • age >18;
  • BMI ≥20 kg/m^2;
  • HbA1c 7.0-9.0 %;
  • receiving metformin therapy at least 1500 mg/day for at least 8 weeks before screening;
  • plasma triglycerides <400 mg/dL, plasma LDL-cholesterol < 250 mg/dL;
  • stabile daily dose(s) of hypolipidemic drugs (statins, ezetimibe) for at least 7 weeks prior to the day of randomization;
  • adequately controlled blood pressure (≤140/90 mmHg) to be maintained during the study according to Standard of Care;
  • able to swallow whole tablets.

  • pregnancy or willingness to became pregnant;
  • severe liver dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times upper limit of normal);
  • renal failure with glomerular filtration rate (eGFR) <60 ml/min/1.73m^2;
  • major cardiovascular event (myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack) within 12 weeks before screening;
  • severe infections (such as HIV and HCV);
  • any malignancy within 5 years before screening.
University of Palermo logoUniversity of Palermo
責任者
Manfredi Rizzo, 主任研究者, Associate Professor, University of Palermo
連絡先情報がありません。
1 1カ国の場所
University Hospital of Palermo, Palermo, 90127, Italy