A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Composite
研究概览
简要总结
Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.
详细描述
Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan. This will allow time for a run in period for the titration of Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals ≥ 18 years old with established T2DM on metformin only
- •or dual therapy of metformin plus a sulphonylurea or pioglitazone
- •with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy
排除标准
- •Are pregnant or breast feeding
- •Suffer from terminal illness
- •Have significant renal or liver impairment
- •Are unable to provide informed consent
- •Have severe and enduring mental health problems
- •Are not primarily responsible for their own care
- •Are receiving insulin therapy
- •Type 1 diabetes
研究组 & 干预措施
Monotherapy 2
addition of Sulfonylurea or Pioglitazone to Metformin
干预措施: Sulfonylurea or Pioglitazone (Drug)
Dual Therapy 1
Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
干预措施: Liraglutide (Drug)
Dual therapy 2
Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
干预措施: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide (Drug)
Monotherapy
Addition of Liraglutide to Metformin
干预措施: Liraglutide (Drug)
结局指标
主要结局
Composite
时间窗: 12 weeks following post Ramadan cinical assessment
A composite endpoint of a reduction in weight, reduction/maintenance of HbA1c and elimination of severe hypoglycaemic (defined as hospital admission) events post intervention.
次要结局
- HbA1c only(same as primary, 12 weeks following post Ramadan cinical assessment)