NCT02648217已完成3 期
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Change in HbA1c (%) (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age at least 18 years at the time of signing informed consent. Algeria: Male or female, age at least 19 years at the time of signing informed consent
- •Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (Visit 1)
- •Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (Visit 1)
- •Subjects not on any OAD(s) (oral anti-diabetic drug) prior to trial participation OR subjects on fixed daily dose(s) of OAD(s) for at least 90 days prior to screening (Visit 1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject medical record) Insulin secretagogues (sulfonylureas (SU) and glinides), Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), a-glucosidase inhibitors, Sodium-glucose co-transporter 2- inhibitors (SGLT2 Inhibitors ) (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
- •HbA1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis)
- •Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting
- •Willing to give blood during Ramadan
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 (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour)
研究组 & 干预措施
IDegAsp U100 BID
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
BIAsp U100 BID
Active Comparator
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Change in HbA1c (%) (Glycosylated Haemoglobin)
时间窗: From week 0 to end of Ramadan (day 29 of Ramadan)
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
次要结局
- Change in Fructosamine(From week 0 to end of Ramadan (day 29 of Ramadan))
- Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )(End of Ramadan (day 29 of Ramadan))
- Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)(End of Ramadan (day 29 of Ramadan))
- Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(From week 0 to 4 weeks post Ramadan)
- Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic(From week 0 to 4 weeks post Ramadan)
- Change in Fasting Plasma Glucose (FPG)(From week 0 to end of Ramadan (day 29 of Ramadan))
研究者
研究点 (1)
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