2024-518403-22-00招募中4 期
Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment
Sanofi Aventis S.A.14 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月13日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Change from baseline to Month 5 in the percentage of Time in Range (TIR)
研究概览
简要总结
To evaluate the efficacy and safety of switching treatment with insulin glargine 100U/ml (Gla-100) to Insulin glargine 300U/ml (Gla-300) using CGM in patients with T2DM and renal impairment
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients with DM ≥ 18 years of age
- •Diagnosed with Type 2 Diabetes Mellitus ≥ 3 years prior to study enrolment.
- •Participants currently treated with Gla-100 for at least 4 months prior to enrolment with or without oral antidiabetics.
- •HbA1c ≥ 7.5 y < 9% within 3 months prior to enrolment.
- •Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min at least 4 weeks prior to enrollment
- •BMI between 25 and 40 kg/m2
- •Ability and willingness to wear the Freestyle IQ Pro as required by the protocol Signed informed consent form
排除标准
- •Pregnant or lactating women
- •Patients who have been hospitalized for more than 7 days in the month prior to recruitment
- •Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids)
- •Participants enrolled during the study period in another clinical study.
- •Participants with basal-bolus regimen
结局指标
主要结局
Change from baseline to Month 5 in the percentage of Time in Range (TIR)
Change from baseline to Month 5 in the percentage of Time in Range (TIR)
次要结局
- Mean glucose profile over 24 hours
- % Coefficient of variation
- % Time below target glucose Range (TBR)
- % Time above target glucose Range (TAR)
- Change from baseline to Month 5 in HbA1c
- Change from baseline to Month 5 in Fasting Plasma Glucose (FPG)
- Number of participants with at least one hypoglycemia event
- Change from baseline to Month 5 in DTSQc
- Number of participants with adverse events
研究者
Fernando
Scientific
Sanofi Aventis S.A.
研究点 (14)
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