EUCTR2017-001061-24-CZ进行中（未招募）1 期
A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients with Type 2 Diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
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
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •1. Male or female subjects, 18-75 years of age, both inclusive, at the time of the first screening visit. Women must be either using adequate, highly effective methods of contraception, be post-menopausal or be considered sterile due to tubal ligation or other surgical procedures at the time of randomization. Sexually active men with a female partner of childbearing potential must agree to use condom from enrolment up to at least 3 months after the study end.
- •2. Subjects with type 2 diabetes mellitus diagnosis whose HbA1c levels are =7.0% and =10.0% (53 mmol/mol to 86 mmol/mol, respectively) at screening.
- •3. Stable therapy (for at least 90 days prior to randomization) with metformin.
- •4. Body mass index (BMI) = 25.0 kg/m², and = 45.0 kg/m².
- •5. The subject is able to understand and comply with protocol requirements.
- •6. The subject is able and willing to give 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Exclusion Criteria
- •1. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
- •2. Past or present significant co-morbidity (other than type 2 diabetes mellitus) including, but not limited to: Active liver disease (other than asymptomatic non-alcoholic fatty liver disease), significant renal disease (including creatinine clearance < 45 ml/min by the Modification of Diet in Renal Disease (MDRD) method, congestive heart failure (NYHA class III or IV), myocardial infarction within the past 12 months, unstable angina pectoris.
- •3. Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
- •4. Currently receiving medical treatment for obesity.
- •5. History of bariatric surgery.
- •6. Current alcohol abuse.
- •7. Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors, DPP4-inhibitors, GLP-1 analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
- •8. Use of thiazolidinediones (glithazones) lasting for more than one month within 90 days of randomization.
- •9. Regular use of insulin or insulin analogues.
- •10. History or presence of sensitivity or allergy to the study drug or drugs, to their components, or drugs of these classes or a history of drug or other allergy that contraindicates participation.
- •11. History of sarcoma or other malignancy within the past five years, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
- •12. Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.
- •13. Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to randomization or during the treatment phase of the trial.
- •14. Positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
- •15. ALT or AST > 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities.
- •16. Clinically significant ECG abnormalities, as judged by the investigator.
研究者
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