EUCTR2022-001485-35-HU进行中（未招募）1 期
A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Each patient must meet all of the following criteria to be enrolled in this trial:
- •1. Is an adult aged =18 years at screening.
- •2. Was diagnosed with T2DM of >1-year duration and had glycemic levels above target with OADs with or without GLP-1 RA (oral or injectable) at stable doses for =3 months before the screening period.
- •3. Has an HbA1c =7.5% and =10.5% at screening.
- •4. Has renal impairment, as defined by an eGFR of <60 mL/min/1.73m2 and =15 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation; National Kidney Foundation 2022).
- •5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
- •6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
- •7. Is capable of understanding the written informed consent, and provides signed written informed consent.
- •8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
- •9. Is willing and able to fast without having administered study drug for scheduled site visits. (Note: Fasting is defined as no intake of food or drink, except water, in the 8 hours before blood sampling.)
- •Specific to the CGM Substudy
- •10. Is willing and able to wear the CGM device continuously for 14 days to capture measures for baseline CGM assessment (from Week –2 to Week 0) and again for two 14-day intervals during the
- •treatment period (ie, from Week 12 to Week 14 and from Week 22 to Week 24).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •Patients meeting any of the following criteria will be excluded from the trial:
- •1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
- •2. Has a body mass index (BMI)* >45 kg/m² during the screening period.
- •*Body weight and height will be recorded during the screening period for the calculation of BMI (BMI = weight [kg]/[height (m)]2).
- •3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [eg, blurred vision, difficulty speaking, feeling faint,
- •difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels).
- •4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening.
- •5. Has been exposed to other investigational drug(s) within 1 month
- •5 half-lives from screening, whichever is longer.
- •Specific to the CGM Substudy
- •6. Uses substances known to interfere with CGM readings, such as aspirin-containing products (>650 mg/day of acetylsalicylic acid) or supplements containing vitamin C (>1000 mg/day of ascorbic
- •acid) taken during the 14-day periods of baseline CGM assessment (ie, from Week –2 to Week 0) and the treatment period (ie, from Week 12 to Week 14 and from Week 22 to Week 24).
研究者
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