CTRI/2015/12/006437已完成3 期
34-week, randomised (1:1), parallel group, two-arm, open-label, multicentre, multinational,controlled trial comparing the efficacy and safety of IDegAsp BID vs. BIAsp 30 BID withrespect to change in HbA1c from baseline to end of treatment, both with or without OAD(s) before,during and after Ramadan in subjects with T2DM who have expressed their intention to fast during Ramadan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novo Nordisk
- 入组人数
- 357
- 试验地点
- 9
- 主要终点
- Change in HbA1c (%) from baseline
研究概览
简要总结
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. Globally 6 countries are participating.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /xml:namespace prefix = w ns = "urn:schemas-microsoft-com:office:word" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female, age ≥ 18 years at the time of signing informed consent.
- •Subjects diagnosed with T2DM (diagnosed clinically) ≥ 24 weeks prior to day of screening (V1).
- •Subjects who have expressed their intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting.
- •Subjects who are willing to give blood during Ramadan.
- •Subjects treated with any premix/selfmix or basal insulin regimen ≥ 90 days prior to the day of screening (V1).
- •Subjects who are on stable daily dose(s) including any of the following anti-diabetic drug(s)/regimens within 90 days prior to the day of screening (V1): a.
- •Biguanides (metformin ≥ 1500 mg or maximum tolerated dose documented in the subject medical record) b.
- •Insulin secretagogues (sulfonylureas and glinides), DPP-4 inhibitors, α-glucosidase inhibitors, SGLT-2 inhibitors (≥ half of the maximum approved dose according to local label or Maximum Tolerated Dose as documented in subject medical record)
- •Body mass index (BMI) ≤ 45.0 kg/m
- •Subjects who are able and willing to adhere to the protocol including self-measurement of plasma glucose according to the protocol".
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial.
- •Participation is defined as signed informed consent
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- •Receipt of any investigational medicinal product within 4 weeks prior to the day of screening (Visit 1)
- •Any disorder, which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
- •Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening (Visit 1)
- •Renal impairment estimated as the Glomerular Filtration Rate (eGFR) 60 mL/min (defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening (Visit 1)
- •Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) in the previous 90 days prior to the day of the screening
- •Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1)
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV on the day of screening (Visit1)
- •Planned coronary, carotid or peripheral artery revascularisation on the day of screening (Visit 1)
- •Inadequately treated blood pressure as defined as Class 2 hypertension or higher (systolic ≥160 mmHg or diastolic ≥100 mmHg) at screening (Visit 1)
- •Treatment with any medication for the indication of diabetes or obesity other than those stated in the inclusion criteria in a period of 90 days before the day of screening (Visit 1)
- •Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on an frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
- •Proliferative retinopathy or maculopathy requiring acute treatment.
- •Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation (Visit 2)
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
- •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 1), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour).
结局指标
主要结局
Change in HbA1c (%) from baseline
时间窗: (week 0) to end of Ramadan (day 29 of Ramadan
次要结局
- To compare efficacy parameters, safety and patient reported outcomes (PROs) of IDegAsp BID and BIAsp 30 BID((week 0) to end of Ramadan (day 29 of Ramadan))
研究者
研究点 (9)
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