A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Number of women willing to be randomised
研究概览
简要总结
The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This feasibility trial will inform the design of a future substantive multicentre trial to test the hypothesis that combination therapy with glibenclamide and metformin could reduce the number of pregnant women with GDM who require insulin and would be superior to metformin and insulin in terms of acceptability and cost effectiveness.
Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised to either receive glibenclamide (test arm) or standard care with insulin, both in addition to their maximum tolerated dose of metformin. Patients will be recruited from three of the antenatal clinics.
This is a feasibility study in preparation for a large multicentre randomised trial to test the hypothesis that the addition of glibenclamide to metformin (combination therapy) could reduce the number of pregnant women with gestational diabetes mellitus requiring insulin, without compromising glycaemic control or other clinical outcomes. The investigators hypothesise that combination therapy with metformin and glibenclamide is likely to be preferable to metformin and insulin in terms of acceptability and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with gestational diabetes who fail to achieve "adequate glycaemic control" on maximum tolerated dose metformin
- •Inadequate glycaemic control is defined according to the SIGN 116 guidelines.
排除标准
- •Pregnant women requiring insulin prior to 20 weeks gestation or after 36 weeks gestation.
- •Pregnant women not taking at least 500mg metformin daily.
- •Patients with suspected Type 1 diabetes mellitus presenting in pregnancy.
- •Women with allergies to either glibenclamide or insulin or any of their excipients.
- •Women with any contraindications to sulfonylurea therapy.
- •Women unable to give informed consent.
研究组 & 干预措施
Current Standard Care
Insulin + Metformin
干预措施: Insulin (Drug)
Treatment
Glibenclamide + Metformin
干预措施: Glibenclamide (Drug)
结局指标
主要结局
Number of women willing to be randomised
时间窗: 2 years
* Retention - proportion of women randomised who remain in the study to provide outcomes * Adherence - proportion of clinicians who adhere to the treatment regimen(s)
次要结局
- Glycaemic control(2 weekly)
- Patient satisfaction(36-38 weeks gestation)
- Clinical outcomes(36 weeks)
- Clinical outcome(40 weeks)
- Clinical Outcome(2 days)