EUCTR2011-005499-41-DK进行中（未招募）不适用
A double blind, double dummy, randomised, multi-centre study to assess the tolerability and efficacy profile of vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 552
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
- •- Confirmed T2DM diagnose
- •- Plan to fast during Ramadan
- •-Treated with a combination of a stable dose of metformin and an SU for at least 12 weeks and HbA1c <= 8.5% at Visit 1
- •- Taking a sulfonylurea treatment less than 3 years prior to Visit 1
- •- Body mass index (BMI) >= 22 AND <= 45 KG/M2 at Visit 1
- •Other protocol-defined inclusion criteria may apply
- •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 497
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •-Pregnant or nursing (lactating) women
- •-History of hypersensitivity to any of the study drugs
- •-Patients taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component
- •- Inability to comply with the study procedures or medications
- •Other protocol-definied exclusion criteria may apply
研究者
相似试验
Unknown
4 期
A multi-centre study to assess tolerabilty and efficacy of the vildagliptin plus metformin versus gliclazide plus metformin inMuslim patients with Type 2 diabetes fasting during RamadaCTRI/2015/05/005821ovartis Healthcare Private Limited552
进行中（未招募）
1 期
Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during RamadaType 2 Diabetes MellitusEUCTR2011-005499-41-ESovartis Farmacéutica S.A.557
进行中（未招募）
1 期
Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during RamadaType 2 Diabetes MellitusEUCTR2011-005499-41-GBovartis Pharma Services AG557
进行中（未招募）
不适用
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进行中（未招募）
不适用
Phase IIb safety and efficacy study of different oral doses of BAY 94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease aloneSubjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or moderate chronic kidney disease aloneMedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 17.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 17.0Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849EUCTR2012-002627-15-DEBayer HealthCare AG1,510