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治験 NCT02426541 (DERISC)（対象：2型糖尿病）は完了です。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。 | ||
アストラゼネカEffects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus (DERISC) 第IV相・フェーズ4 55 無作為化 二重盲検 プラセボ対照
An 8-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase IV Study to Evaluate Dapagliflozin 10 mg Once Daily Effects on Insulin Resistance in Subjects With Type 2 Diabetes Mellitus
- DERISC
- D1690C00025
- 2014-005377-36 (EudraCT番号)
Dapagliflozin
Placebo
Insulin resistance
Insulin sensitivity
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Dapagliflozin Dapagliflozin Once Daily 10 mg | Dapagliflozin Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks |
プラセボ対照薬Placebo Matching placebo for Dapagliflozin Once Daily 10 mg | プラセボ Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake | Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg) | From baseline to Week 8 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake | Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET | Baseline to Week 8 |
Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8 | Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET | Baseline to Week 8 |
Provision of signed informed consent prior to any study specific procedures.
Female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
Type 2 Diabetes mellitus defined as HbA1c of ≥ 6.5% and ≤ 10.5%.
Stable (≥ 3 months) T2D treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (DPP-IV)
Body mass index (BMI) ≤ 40 kg/m2.
Female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
- Hysterectomized females
- Postmenopausal women, defined as women who have not had a menstrual period within 1 year
Any condition that is contraindicated with MRI such as, but not limited to, having a pacemaker or claustrophobia.
Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
Recent Cardiovascular Events in a patient:
- Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- Acute Stroke or Transient Ischemic Attack (TIA) within two months prior to enrolment
- Less than two months post coronary artery revascularization
Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
Blood pressure at enrolment: Systolic BP ≥165 mm Hg and/or diastolic BP ≥100 mm Hg
Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
On insulin, GLP-1 or other oral antidiabetic drug treatment (metformin or both metformin and DPP-IV allowed) or using other medications known to affect glucose metabolism.
Any clinically significant abnormalities in physical examination, Electrocardiography (ECG) or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
- Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
Body weight loss greater than 5% within 3 months prior to Visit 1.
Previous PET scan
History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
アストラゼネカ