EUCTR2016-002826-35-PL进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea alone or in combination with Metformin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or with Metformin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 625
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Patients with T2D treated with a sulfonylurea (=half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with metformin (=1500 mg per day or maximum tolerated dose[documented]) each at a stable dose for at least 12 weeks without a dose adjustment before enrollment.
- •-Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 469
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •-At the time of screening age <18 years.
- •-Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
- •-Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
- •-Women of childbearing potential with no effective contraceptive method.
- •-Treated with an antidiabetic pharmacological regimen other than a sulfonylurea at a stable dose with or without metformin within 12 weeks preceding the screening visit.
- •-Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
- •-History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
- •-History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
- •-History of severe hypoglycemia within 6 months prior to the Screening visit.
- •-Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency
- •-Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN)
- •-Total bilirubin: >1.5 times ULN (except in case of Gilbert’s syndrome).
- •-Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
- •-Pregnancy, breastfeeding.
- •-Patient is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the patient’s diary as required per protocol.
研究者
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