CTRI/2024/10/075222尚未招募4 期
A Multicentre Phase IV single arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Insulin Glargine and Lixisenatide in adult patients with Type 2 diabetes who are sub optimally controlled on oral anti-hyperglycemic drugs and/or basal Insulin/GLP-1 RA
Sanofi Healthcare India Private limited,12 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 12
- 主要终点
- To evaluate the safety of iGlarLixi in Adults with sub optimally controlledT2D with obesity despite treatment with Metformin +/- OADs and/or basal insulin/GLP-1 RA during 24 weeks of treatment period.
研究概览
简要总结
| This is an intervention, phase IV, single-arm |
| study to assess the safety and efficacy of iGlarLixi iGlarLixi in adult |
| patients with Type 2 diabetes. |
Study details include:
• The study duration will be up to 27 weeks
• The treatment duration will be approximately 24 weeks
• The number of visits will be 16
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be ≥18 years of age, at the time of signing the informed consent. I
- •Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening. I
- •HbA1c between less than equal to 7.5percent and morethan equal to 10.5percent inclusive, during screening. I
- •Participant with BMI more thansequalto 25 kg/m2 (as per Endocrine Society of India, Ref 12) I
- •Male or Female -Female participants- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies.
- •Not a woman of childbearing potential (WOCBP). OR.
- •A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27). I
- •Signed informed consent.
排除标准
- •Type 1 Diabetes mellitus or any diabetes other than T2DM.
- •Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy E
- •Basal insulin dose more than 50 U at screening.
- •Any clinically-significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment.
- •Known presence of factors that interfere with the HbA1c measurement (e.g., specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival).
- •Proliferative retinopathy or maculopathy requiring treatment according to the Investigator.
- •Use of weight loss drugs (including over the counter and herbal medications) within 12 Weeks prior to the screening visit, Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.
- •Likelihood to require treatment prohibited by the protocol during the study.
- •Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment.
- •Any specific situation during study implementation or course that may raise ethics considerations.
- •History of hypoglycemia unawareness E
- •Patients with known hypersensitivity to lixisenatide, insulin glargine or to any of the inactive ingredients in the formulation.
- •History of drug or alcohol abuse within 6 months prior to screening visit.
- •Patient not suitable for participation, whatever the reason, as judged by the Investigator, or participants potentially at risk of noncompliance to the study procedures (eg, not willing and or not able to perform self-monitoring of plasma glucose, or to follow health care providers instructions on titration protocol) l.
- •Participants who withdraw consent during the screening (starting from signed ICF).
- •Participants unable to use a blood glucometer and accept to perform SMBG E
- •Participants unable to use the diary and accept to report daily information as required E
- •Participants with conditions or concomitant diseases making them non-evaluable for the study endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the last 3 months prior to the screening visit).
- •Known history of drug or alcohol abuse within 6 months prior to the screening visit.
- •Any technical or administrative reason (eg, patient homeless) that made it impossible to enroll the patient in the study.
- •Participants who had taken other investigational drugs within 1 month or 5 half-lives from screening, whichever was longer.
结局指标
主要结局
To evaluate the safety of iGlarLixi in Adults with sub optimally controlledT2D with obesity despite treatment with Metformin +/- OADs and/or basal insulin/GLP-1 RA during 24 weeks of treatment period.
时间窗: At baseline, at week 24 and week 25 (follow up period).
次要结局
- -To assess the efficacy of iGlarLixi on glycemic control (HbA1c/ FPG/ PPG /fasting SMPG) in obese Adults with sub optimally controlled T2D despite treatment with Metformin +/- OADs and/or basal insulin/GLP-1 RA after 24 weeks of treatment.
研究者
研究点 (12)
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