EUCTR2007-006095-11-FR进行中（未招募）1 期
An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 710
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
- •Provision of informed consent
- •Diagnosed with type 2 diabetes
- •Man or women equal to or above 18 years of age
- •Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks
- •Women of childbearing potential must be using an adequate method of contraception.
- •HbA1c above 6.5% and below or equal to 10.0%
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- •Pregnant of breastfeeding patients
- •Insulin therapy within 1 year
- •Previous treatment with any DPP-4 inhibitor
- •Treatment with thiazolidinedione within 12 weeks
- •Treatment with systemic glucocorticoids other than replacement therapy, CYP460 3A4 inducers and/or HIV treatment/antiviral drugs
- •Potential allergy to metformin, saxagliptin, sitagliptin, or placebo
- •Contraindications to therapy as outlined in the saxagliptin IB, metformin package insert or sitagliptin package insert
- •Congestive heart failure defined as NYHA class III or IV and/or left ventricular ejection fraction equal to or below 40%
- •Significant cardiovascular history within the 6 past months
- •History of haemoglobinopathies, alcohol abuse or illegal drug abuse
- •Involvement in the planning and conduct of the study
- •Previous enrolment or randomization of treatment in the present study
- •Participation in a clinical study during the last 90 days
- •Donation of blood, plasma or platelets within the past 3 months
- •Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study
- •Suspected or confirmed poor protocol or medication compliance as judged by the investigator
- •Serum creatinine equal to or above 133 micromol/L, for men and 124 micromol/L for women
- •Active liver disease and/or significant abnormal liver function
- •Creatinine kinase equal or above 3xULN
- •History of positive serologic evidence of current infectious liver disease
- •Any clinically significant abnormality identified on physical examination or laboratory tests or ECG, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
研究者
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