EUCTR2015-005522-19-DE进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE-DOSE, TWO-CENTRE, SAFETY AND EFFICACY STUDY OF CO-ADMINISTRATION OF TESOFENSINE/METOPROLOL TREATMENT IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Saniona, A/S0 个研究点目标入组 60 人开始时间: 2015年12月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1.Males and females
- •2.Confirmed diagnosis of T2DM (either by being on anti-diabetic medication or by confirmed or repeated laboratory findings)
- •3.18-70 years of age
- •4.Normal BP or well managed hypertension (only if dose of BP medication(s) has been stable for at least two months)
- •5.Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for at least 2 months)
- •6. No history of CV disease (as specified in exclusion criteria 7-10) or any other clinically relevant major disease
- •7.On any dose of metformin stable for at least two months, or
- •8.On any dose of metformin plus one other oral antidiabetic agent (except TZDs); the other oral agent will be washed out prior to randomization
- •9.HbA1c =7.0%
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.BP > 140/90
- •2.HbA1c > 8.5%
- •3. Fasting Plasma glucose > 200 mg/dL at screening
- •4.HR = 90, <50 bpm
- •5.BMI < 27 kg/m2
- •6.Hypersensitivity to tesofensine/metoprolol
- •7.Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
- •8.History of myocardial infarction or stroke within 12 months prior to enrolment
- •9.History of coronary revascularization or angioplasty in the last 12 months prior to enrolment
- •10.Patients reporting angina in the last 6 months prior to enrolment
- •11.Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
- •12.Any clinically significant cardiac arrhythmia
- •13.Treatment with calcium channel blockers or beta blockers or their combination
- •14.Current treatment with medications which should not be co-administered according to the excluded medications list (Appendix I)
- •15.Concomitant use of monoaminooxidase inhibitors
- •16.Bulimia or anorexia nervosa
- •17.Any agent used for weight loss within the last 3 months
- •18.Patients with history of major depressive disorder or any history of suicide attempt/ideation
- •19.Patients with family history of severe psychiatric diseases
- •20.Patients using selective serotonin reuptake inhibitors (SSRIs), antidepressants or anxiolytics.
- •21.PHQ-9 (Patient Health Questionannire) score = 10 or any score > 0 on question 9
- •22.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods or postmenopausal women being amenorrheic for less than 1 year and not using highly effective contraceptive methods
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