ACTRN12610000839000已完成1 期
A Placebo Controlled Single Ascending Dose Phase 1 study for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-859 in Patients with Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 62 Years（—）
- 性别
- All
入选标准
- •1. Age 21 to 62 years
- •2. Body Mass Index (BMI) between 25 and 40 kg/m2 inclusive and a minimum body weight of 50 kg
- •3. Negative serum pregnancy test for females of childbearing potential
- •4. Diagnosis of Type 2 diabetes at least 6 months prior to dosing as documented in the patient’s medical history
- •5. Fasting plasma glucose level (inclusive) of 130-260 mg/dL (7.22 – 14.44 mM inclusive) AND glycosylated hemoglobin (HbA1c) range (inclusive) of 7 – 10.5% for patients on metformin alone or 6.5-10% for patients on metformin and sulfonylurea [Patients on sulfonylurea will stop taking it for 2 weeks prior to dosing and will receive metformin during study]
- •6. Diet and exercise program and on a fixed dose of oral diabetic agent (metformin alone or metformin and sulfonylurea) for at least 3 months prior to enrollment
- •7. Willing and able to give informed consent
- •8. QT correction (QTc) value of less than 450 msec by ECG
排除标准
- •1. Patients who have received treatment for any bacterial, viral or fungal infection within 30 days of prior to study drug dosing
- •2. Any oral antidiabetic monotherapy (except metformin or sulfonylurea) within 3 months prior to enrollment
- •3. Currently taking or have been on treatment with thiazolidinedione (TZD) within the past 3 months
- •4. Pancreatitis within 5 yrs prior to enrollment
- •5. Documented history of or current significant cardiovascular, cerebrovascular, renal or hepatobillary disease
- •6. Pancreatic enzymes (amylase, lipase) outside laboratory normal range
- •7. Fasting serum triglycerides > 500 mg/dL (5.6 mmol/L)
- •8. Use of gastric motility drugs within one week prior to study enrollment
- •9. Positive drugs screen and alcohol breath test at screening or at admission
- •10. Positive serology for Hepatitis B (HBV), Hepatitis C (HCV), or Human Immunodeficiency Virus (HIV). Must also have no prior history of HBV or HCV virus infection
- •11. Prior history of cancer excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
- •12. Women who are pregnant or breastfeeding
- •13. Unwilling to use two effective birth control methods while on study
- •14. Unwilling to abstain from recreational drug use
- •15. Unwilling to refrain from alcohol use at least 48 hours prior to screening and enrollment.
- •16. Any prior treatment with glucagon-like peptide-1 (GLP-1) analog (e.g. Byetta, Victoza)
- •17. Treatment on dipeptidyl peptidase IV (DPP IV) inhibitor within 3 months prior to screening
- •18. Treatment with an investigational drug within past 30 days prior to screening
- •19. Treatment with insulin within the past 3 months prior to screening
研究者
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