NCT01917656已完成4 期
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Change in Fructosamine From Start of Ramadan to End of Ramadan
研究概览
简要总结
This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Subjects diagnosed with T2DM and treated with metformin equal to or above 1000 mg/day and SU (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
- •- HbA1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)
- •- Body Mass Index (BMI) equal to or above 20 kg/m^2
- •- Subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting
排除标准
- •- Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour)
- •- Any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
- •- History of chronic pancreatitis or idiopathic acute pancreatitis
- •- Screening calcitonin value equal to or above 50 ng/L
- •- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- •- Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
- •- Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula)
- •- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
- •- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
研究组 & 干预措施
Liraglutide+Metformin
Experimental
Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
干预措施: liraglutide (Drug)
Liraglutide+Metformin
Experimental
Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
干预措施: metformin (Drug)
Sulphonylurea and Metformin
Active Comparator
Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
干预措施: metformin (Drug)
Sulphonylurea and Metformin
Active Comparator
Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
干预措施: sulphonylurea (Drug)
结局指标
主要结局
Change in Fructosamine From Start of Ramadan to End of Ramadan
时间窗: Day -1, day 29
The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).
次要结局
- Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)(Baseline, day 29)
- Fructosamine at End of Ramadan(Day 29)
- Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)(Day -1, day 29)
- Change From Baseline to End of Ramadan in Fasting Plasma Glucose(Baseline, day 29)
- Change From Baseline to End of Ramadan in Body Weight(Baseline, day 29)
- Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)(Visit 14 (4 weeks post Ramadan))
- Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes(Visit 14 (4 weeks post Ramadan))
- Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.(Day -1 to day 29)
- Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.(Day -1 to day 29)
研究者
研究点 (1)
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