EUCTR2007-003548-32-IT进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control - ND
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
- 500
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
- •a.Patient has type 2 diabetes mellitus (T2DM).
- •b.Patient has moderate or severe renal insufficiency as indicated by an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 and is not likely to require dialysis throughout the duration of the study.
- •Note: Glomerular filtration rate is estimated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 6.8).
- •c.Patient is ≥ 30 years of age on day of signing informed consent.
- •d.Patient is unlikely to conceive, as indicated by at least one ?yes? answer to the following questions:
- •1)Patient is a male.
- •2)Patient is a surgically sterilized female.
- •3)Patient is a postmenopausal female ≥ 45 years of age with > 2 years since last menses.
- •4)Patient is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception.
- •Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
- •e.Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.a.Patient has type 2 diabetes mellitus (T2DM).
- •b.Patient has moderate or severe renal insufficiency as indicated by an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 and is not likely to require dialysis throughout the duration of the study.
- •Note: Glomerular filtration rate is estimated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 6.8).
- •c.Patient is ≥ 30 years of age on day of signing informed consent.
- •d.Patient is unlikely to conceive,
- •f.Patient is likely to be able to complete the study.1)Patient is currently not on an antihyperglycemic agent (off therapy for ≥12 weeks) and has a Visit 1 HbA1c ≥7% and ≤9%.
- •Are the trial subjects under 18? yes
- •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
- •a.Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •b.Patient is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months).
- •c.Patient intends to be involved in weight loss intervention outside that prescribed by the study.
研究者
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A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic ControlType II Diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2007-003548-32-LTMerck & Co., Inc.500