A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 124
- 试验地点
- 18
- 主要终点
- Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]
研究概览
简要总结
The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs [OADs] with or without a glucagon-like peptide 1 receptor agonist [GLP1 RA]), as measured by continuous glucose monitoring (CGM).
The total study duration per participant was approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled.
- A screening period of up to 2 weeks
- A run-in period of up to 2 weeks, including the baseline period
- A 16-week, open-label treatment period
- A 2-week post-treatment safety follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period
- •HbA1c ≥9-13% during the run-in period
- •On at least 2 OADs with or without GLP-1 RA with stable doses (for both) for 3 months prior to the screening period
- •Willing and able to wear the CGM device continuously for 14 days to capture CGM measures at baseline until the next site visit and again towards the end of the treatment period
- •Willing and able to prick fingers a minimum of 2-4 times per week utilizing sterile lancets provided along with a manual blood glucose meter kit
- •Willing to discontinue the daily (oral or injectable) or weekly GLP-1 RA or DPP 4i prior to administration of iGlarLixi (Soliqua 100/33)
- •Willing and able to inject iGlarLixi (Soliqua 100/33) and increase dose as needed to achieve SMPG target
- •Non-pregnant, non-breastfeeding women utilizing a highly-effective contraceptive method or of non-childbearing potential
排除标准
- •Type1 Diabetes mellitus (T1DM) or any other types of diabetes, except T2DM
- •On meglitinides (eg, nateglinide, repaglinide)
- •Body mass index (BMI) >40 kg/m² during the screening period
- •Any current or previous skin conditions, including (but not limited to) severe psoriasis, burns, eczema, scarring, excessive tattoos, that would inhibit the proper wearing of the CGM device
- •History of severe nausea and vomiting leading to subsequent discontinuation of GLP-1 RA
- •Known history or presence of clinically significant pancreatitis or gastroparesis
- •Participants with an episode of severe hypoglycemia or with hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [for example, 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) diagnosed within the 6 months prior to the screening period
- •Participants with personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposed to MTC (eg, multiple endocrine neoplasia syndromes)
- •Significant current (within past 2 months) and/or expected use of medications known to affect glycemia (eg, ≥5 mg/day prednisone)
- •Use of substances known to interfere with CGM readings, such as aspirin-containing products (>650 mg/day of salicylic acid) or supplements containing vitamin C (>1000 mg/day of ascorbic acid) during the 14 days of CGM at either baseline or end of treatment period
- •Previous treatment with any insulin (except for short term treatment due to intercurrent illness, including gestational diabetes, at the discretion of the investigator)
- •Had used weight loss drugs (including over the counter and herbal medications) within 12 weeks before the screening visit
- •The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
研究组 & 干预措施
iGlarLixi
iGlarLixi (i.e., insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.
干预措施: Insulin glargine/Lixisenatide (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]
时间窗: Baseline (Days -14 to -1) and Week 16
The percentage of time spent in the glycemic target range of 70 to 180 mg/dL was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements. Baseline is defined as the first 14 evaluable days of evaluable continuous glucose monitoring (CGM) data prior to first day of treatment. CGM compliance is defined as 1) at least 8 out of 14 days (not necessarily consecutive) have 100% of evaluable CGM data per 24-hour period (at least 8 days with 96 records minimum per day) OR 2) at least 9 out of 14 days (not necessarily consecutive) have ≥89% of evaluable CGM data per 24-hour period (at least 9 days with 85 records minimum per day) OR 3) at least 10 out of 14 days (not necessarily consecutive) have at least ≥80% of evaluable CGM data per 24 hour period (at least 10 days with 77 records minimum per day).
次要结局
- Percentage of Participants Who Achieved Coefficient of Variation <36%(Week 16)
- Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%(Week 16)
- Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)(Baseline (Days -14 to -1) and Week 16)
- Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)(Baseline (Days -14 to -1) and Week 16)
- Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration(Baseline (Days -14 to -1) and Week 16)
- Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL(Week 16)
- Change From Baseline to Week 16 in Mean Daily Blood Glucose(Baseline (Days -14 to -1) and Week 16)
- Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire(Baseline (Days -14 to -1) and Week 16)
- Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels(From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks))
- Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal(Baseline (Days -14 to -1) and Week 16)
- Change From Baseline to Week 16 in Time in Range Per Time Blocks(Baseline (Days -14 to -1) and Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks))
- Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours(Baseline (Days -14 to -1) and Week 16)