ACTRN12618001140246已完成1 期
A Phase I Study to Assess the Safety and Efficacy Profile of DCB-DM101 Add-On Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Januvia or Metformin and Jardiance.
VitNovo Australia Pty Ltd0 个研究点目标入组 24 人开始时间: 2018年7月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Male or female aged between 20-80 years old;
- •2. Diagnosed with T2DM (WHO 1999 criteria);
- •3. Current treatment for diabetes is not effective in alleviating T2DM after stable treatment with; Januvia (sitagliptin) greater than or equal to 100 mg/day or Jardiance (empagliflozin) greater than or equal to 10 mg/day with metformin greater than or equal to 850 mg/day for at least 3 months. Janumet or Jardiamet will be accepted for this study if the doses of Januvia and Jardiance in combination with metformin are within the above ranges;
- •4. Current treatments for diabetes including Metformin, metformin XR, Januvia or Jardiance must include morning dosing for at least 7 days prior to Visit 2 and until after Visit 3 assessments have been completed;
- •5. HbA1c of > 6.5% and < 12.0%;
- •6. BMI less than or equal to 45 kg/m2;
- •7. Any other concomitant medications that have been routinely taken should remain at the same dose throughout the study period;
- •8. Participant is willing and able to comply with study procedures and sign informed consent.
排除标准
- •1. Known or suspected allergy to any ingredients of add-on study products;
- •2. Pregnant or lactating or premenopausal with childbearing potential but not taking at least two forms of birth control (at least one of which must be a barrier method) during the study;
- •3. Participated in another clinical trial and received an Investigational drug within 12 weeks prior to the present trial;
- •4. Impaired hepatic function defined as alanine aminotransferase (ALT), aspartate transaminase (AST) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit;
- •5. Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least
- •115 µmol/L) for males and at least 1.2 mg/dL (at least 106 µmol/L) for females;
- •6. With any uncontrolled illness or a history of any illness, e.g. hyperthyroidism, judged by the Investigator that entering the trial may be detrimental to the participant;
- •7. Metformin, Januvia and/or Jardiance contraindications according to the product information;
- •8. Taking any antidiabetic medication other than the combination within the allocated treatment arm (metformin, Januvia, Jardiance, Janumet or Jardiamet). Participants taking other proprietary DPP4 or SGLT2 inhibitors will be excluded from this study;
- •9. Current treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents;
- •10. Uncontrolled hypertension > 170/105 mmHg;
- •11. Clinically significant ECG abnormalities or any acute cardiovascular events within the last 3 months;
- •12. Consuming high doses of vitamin C (greater than or equal to 1,000 mg/day) or other health supplements and herbal remedies for the last two weeks that are considered could affect blood glucose control. Any supplements should be recorded as concomitant medications and dose should remain stable throughout the study period;
- •13. Consumption of alcohol within the last 2 weeks. Participant unwilling to abstain from alcohol consumption for the course of this study. A wash-out period of 2 weeks prior to study entry is required.
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