NCT00258804已完成4 期
Evaluation (Safety and Efficacy) of Treatment With Insulin Glargine and Glimepiride in Patients With Type 2 Diabetes Before, During and After the Period of Fasting in Ramadan
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 450
- 主要终点
- Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
研究概览
简要总结
Primary Objectives :
- To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.
Secondary Objectives :
- To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary).
- To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan.
- To assess patient satisfaction
- To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
- •BMI > 25 and < 40 kg/m2;
- •Willingness to participate and to fast during Ramadan;
- •Patients should be either:
- •Insulin naïve patients
- •Patients already receiving insulin
排除标准
- •Pregnancy (as determined by pregnancy blood test at inclusion visit)
- •Breast- feeding
- •Women of childbearing potential who do not have adequate contraceptive protection
- •Need for treatment during the study period with medications that may interfere with the study protocol
- •Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
- •History of drug or alcohol abuse
- •Severe and unbalanced diabetic retinopathy
- •Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
- •Night shift workers
结局指标
主要结局
Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
All other adverse events before, during and after Ramadan
Patient satisfaction before, during and after Ramadan.
Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)Type 2 Diabetes MellitusNCT01278485Merck Sharp & Dohme LLC726
已完成
不适用
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)Type 2 Diabetes MellitusNCT01285076Merck Sharp & Dohme LLC834
已完成
1 期
A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 DiabeticsDiabetesDiabetes Mellitus, Type 1NCT00964964Novo Nordisk A/S18
撤回
不适用
GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life PracticeDiabetes Mellitus, Type 2NCT01915264Bayer
已完成
不适用
Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetisType1 diabetes using insulinJPRN-UMIN000029837Medical Corporation H.E.C Science Clinic30