NCT06671587招募中4 期
A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]
研究概览
简要总结
This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).
Study details include:
- The study duration per participant will be approximately up to 24 weeks.
- The treatment duration will be up to 20 weeks.
- The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
- Health measurement/Observation: change in TIR as the primary endpoint
- Intervention name: iGlarLixi and Gla-100
- Participant gender: male and female
- Participant age range: adults at least 18 years of age
- Condition/disease: type 2 diabetes
- Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.
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
- •Participants who are diagnosed as T2D of at least 1 year before screening visit
- •Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD
- •Inadequate control
- •Body mass index (BMI) within the range 20-40 kg/m2 (inclusive)
- •Is willing and able to wear the CGM device continuously
- •Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i
- •Not using another CGM device during the study
排除标准
- •Participants with severe renal dysfunction
- •Participants with short life expectancy
- •Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints
- •Participants with conditions/concomitant diseases precluding their safe participation in this study
- •An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit
- •History of clinically significant pancreatitis or severe gastrointestinal disorders
- •Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication/hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Previous treatment with insulin
- •Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i)
- •Use of systemic glucocorticoids
- •Use of weight loss drugs
- •History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy
- •Laboratory findings at the screening visit
- •Participants have any current or previous skin conditions
- •Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
iGlarLixi (insulin glargine/lixisenatide)
Experimental
Participants will receive iGlarLixi once daily for 20 weeks. iGlarLixi is to be initiated with the starting daily dose of 5-10 dose steps on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve glycemic target of ≥80 and ≤110 mg/dL.
干预措施: iGlarLixi (insulin glargine/lixisenatide) (Drug)
Gla-100 (insulin glargine)
Active Comparator
Participants will receive Gla-100 once daily for 20 weeks. Gla-100 is to be initiated with the starting daily dose of 5-10 U on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve and maintain same glycemic target of ≥80 and ≤110 mg/dL.
干预措施: Gla-100 (insulin glargine) (Drug)
结局指标
主要结局
Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]
时间窗: from baseline to Week 20
Superiority of mean change in the percentage of TIR \[3.9-10.0 mmol/L (70-180 mg/dL)\] from baseline to Week 20 of iGlarLixi vs Gla-100
次要结局
- 2a Proportion (%) of participants achieving TIR target as >70%(Week 20)
- 2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)(from baseline to Week 20)
- 2c Change (mg/dL) in mean daily glucose(from baseline to Week 20)
- 2d Proportion (%) of participants achieving composite target of TIR as >70% [3.9-10.0 mmol/L (70-180 mg/dL)] with TAR as <25% [>10.0 mmol/L (>180 mg/dL)] with TBR as <4% [<3.9 mmol/L (<70 m)/dL)](Week 20)
- Change (%) in coefficient of variation (CV)(from baseline to Week 20)
- Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)](from baseline to Week 20)
- Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%(Week 20)
- Proportion (%) of participants achieving ≥5% TIR improvement(from baseline to Week 20)
- Proportion (%) of participants achieving ≥10% TIR improvement(from baseline to Week 20)
- Change (%) in TAR >13.9 mmol/L (>250 mg/dL)(from baseline to Week 20)
- Change (%) in time below range (TBR)(from baseline to Week 20)
- Change in mean glucose standard deviation (SD)(from baseline to Week 20)
- Change (%) in glucose management indicator (GMI)(from baseline to Week 20)
- Proportion (%) of participants achieving CV <36%(Week 20)
- Proportion (%) of participants achieving CV <32%(Week 20)
- Change (%) in HbA1c(from baseline to Week 12 and Week 20)
- Proportion (%) of participants achieving HbA1c <7%(Week 12 and Week 20)
- Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia(Week 20)
- Proportion (%) of participants achieving HbA1c <7% without body weight gain(Week 20)
- Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain(Week 20)
- Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG)(from baseline to Week 12 and Week 20)
- Change (nmol/L) in fasting C-peptide and post-prandial C-peptide(from baseline to Week 12 and Week 20)
- Change (U and U/Kg) in insulin dose(from baseline to Week 20)
- Change (kg) in body weight(from baseline to Week 20)
- Change (%) in TIR [3.9-10.0 mmol/L (70-180 mg/dL)], TAR [>10.0 mmol/L (>180 mg/dL)] and TBR [3.0 mmol/L (<54 mg/dL)] for specific time blocks (6 am-12 pm, 12 pm-6 pm, 6 pm-12 am, and 12 am-6 am)(from baseline to Week 20)
- Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire(from baseline to Week 20)
- AE, serious adverse event (SAE), and adverse event of special interest (AESI)(from screening to week 21)
- Overall hypoglycemia events and rates(from screening to week 21)
- Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates(from baseline to Week 20)
- Confirmed hypoglycemia (ADA Level 1, 2 and 3)(from baseline to Week 20)
研究者
研究点 (1)
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