NCT05552859终止4 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 62
- 试验地点
- 68
- 主要终点
- Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
研究概览
简要总结
The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.
详细描述
The trial will consist of the following periods:
- A screening period of up to 2 weeks,
- A 24-week, open-label treatment period, including a titration period and a maintenance period.
- A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.
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
- •Is an adult aged ≥18 years at screening.
- •Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of >1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period.
- •Has an HbA1c ≥7.5% and ≤10.5% at screening.
- •Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m
- •Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
- •Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
- •Is capable of understanding the written informed consent, and provides signed written informed consent.
- •Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
- •Is willing and able to fast without having administered study drug for scheduled site visits.
排除标准
- •Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
- •Has a body mass index (BMI)* >45 kg/m² during the screening period.
- •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).
- •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.
- •Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer.
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Gla-300 arm
Experimental
Gla-300 will be administered once daily for 24 weeks
干预措施: Insulin glargine 300 U/mL (Drug)
IDeg-100 arm
Active Comparator
Ideg-100 will be administered once daily for 24 weeks
干预措施: Insulin degludec 100 U/mL (Drug)
结局指标
主要结局
Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
时间窗: Baseline to 24 weeks
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24(Baseline to 24 weeks)
- Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24(Baseline to 24 weeks)
- Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period(Baseline to 24 weeks)
- Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24(At week 24)
- Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks)(Baseline to end of study (25 weeks))
- Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period.(Baseline to end of study (25 weeks))
- Rate of Hypoglycemia Per Participant-year(Baseline to end of study (25 weeks)])
- The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period.(Baseline to end of study (25 weeks))
- Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)(Baseline to end of study (25 weeks))
研究者
研究点 (68)
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