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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 1
- 主要终点
- Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
研究概览
简要总结
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed Type 2 Diabetes diagnosis
- •Plan to fast during Ramadan
- •Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
- •Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
- •Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1
排除标准
- •Pregnant or nursing (lactating) women
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •Patients who are 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-defined inclusion/exclusion criteria may apply"
研究组 & 干预措施
Vildagliptin + placebo to Gliclazide
Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Vildagliptin (Drug)
Vildagliptin + placebo to Gliclazide
Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Metformin (Drug)
Vildagliptin + placebo to Gliclazide
Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Placebo to Gliclazide (Drug)
Gliclazide + placebo to Vildagliptin
Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Gliclazide (Drug)
Gliclazide + placebo to Vildagliptin
Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Metformin (Drug)
Gliclazide + placebo to Vildagliptin
Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.
干预措施: Placebo to Vildagliptin (Drug)
结局指标
主要结局
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
时间窗: 1 month
次要结局
- Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs)(visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs)
- Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)(baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks))
- Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)(visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks))
- Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period(1 month)
- mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day(72 hours)
- Treatment adherence during the Ramadan fasting period(1 month)
- Change from visit 3 (pre-Ramadan visit) to endpoint in body weight(From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks))
- Number of unscheduled visit to health care professional(From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks))
- Number of days fasted during the Ramadan fasting period(1 month)
- Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability(Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks))