Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
研究概览
简要总结
This is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved.
详细描述
This will be an open label randomised prospective study that will involve 280 insulin-treated patients with type 2 diabetes and who are receiving a basal insulin as part of their treatment regimen. The power calculation suggests a subject number of 250 but to account for a 10% drop out then 280 patients will be recruited competitively. To account for an estimated 30% screen failure then 400 patients will have to be screened. Of those eligible140 patients will be randomized to insulin glargine U100 and 140 patients randomised to insulin degludec: patients will be stabilised on that regimen so that the primary objective of the study to compare glycemic control for those on insulin glargine U100 compared to those on insulin degludec can be undertaken.
Insulin glargine U100 and insulin degludec will be given once daily in the evening before Ramadan, 10-20 weeks prior to the onset of Ramadan as a run in period for stabilisation, and to be given at Iftar (breaking of the fast) in the evening of Ramadan. In accord with the latest International Diabetes Federation (IDF) guidelines the dose of both the glargine U100 and insulin degludec will be reduced by 15% during Ramadan http://www.idf.org/sites/default/files/IDF-Diabetes and Ramadan (DAR)-Practical-Guidelines-Final-Low.pdf), After Ramadan basal insulin will be increased to that of the pre-Ramadan dose. In accord with the insulin degludec label guidelines (and those of insulin glargine U100), a one to one dose will be implemented if switching from a single basal injection; however, a dose reduction of 20% will be implemented if having to switch from a twice daily basal injection (including those on twice daily insulin glargine U100 randomised to once daily insulin glargine U100). Thus, for those subjects already on once daily insulin glargine U100 and randomised to insulin glargine U100 then no dose reduction will be undertaken, nor will a dose reduction be undertaken for those subjects on once daily insulin glargine U100 and randomised to insulin degludec.
Oral hypoglycemic agents will be on a stable dose that has not been altered in the preceding 12 weeks and will be continued unchanged through the study period
During the 10-20 week run in period to Ramadan fasting blood glucose will be titrated to less than 5mmol/l (90 mg/dl)and insulin dose will be increased or decreased according to the average of three previous fasting blood glucose measurements from the previous week (weekly titration). During Ramadan fasting blood glucose will be measured before Iftar (breaking of the fast) and will aim for a fasting blood glucose of 5mmol/l (90 mg/dl).
Glycosylated hemoglobine (HbA1c) measurement will be done at baseline and 2-4 weeks before Ramadan; two weeks after Ramadan and at the end of the 8 weeks study period following 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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- •Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- •Patients must be on any basal insulin (once daily)
- •Patients must be on any basal insulin (twice daily)
- •Patients on stable dose of oral antidiabetes drugs can be included (No change in the dose for the previous 12 weeks)
- •Body Mass Index <40kg/m2
- •Subjects who have signed informed consent form
- •Patients will be fasting during Ramadan
排除标准
- •Type 1 diabetes
- •Type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin
- •On GLP-1 receptor agonists medication
- •On glinide medication
- •Ischaemic heart disease
- •Left bundle branch block on ECG
- •Active diabetic retinopathy or maculopathy requiring acute treatment
- •Unwilling to follow the protocol
- •Pregnancy, intention to become pregnant, breastfeeding
研究组 & 干预措施
Insulin glargine U100
Intervention: half of the subjects will be randomised to insulin glargine U100 basal insulin treatment (or continued on glargine if already treated) that will be administered daily in the evening
干预措施: Insulin Glargine (Drug)
insulin degludec U100
Intervention: half of the subjects will be randomised to insulin degludec U100 basal insulin treatment that will be administered daily in the evening
干预措施: Insulin Degludec U100 (Drug)
结局指标
主要结局
Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
时间窗: 6 weeks
To measure HbA1c at the end of Ramadan between arms.
次要结局
- Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.(6 weeks)
- Hypoglycemia between arms(6 weeks)
- HbA1c end point achieved(6 weeks)
- Incidence of Treatment-Emergent Adverse Events(14-24 weeks)