CTRI/2024/10/074905进行中（未招募）2 期
Investigation of the safety and efficacy of once weekly NNC0519-0130 in participants with type 2 diabetes – a dose finding study
Novo Nordisk India Pvt Ltd8 个研究点 分布在 1 个国家目标入组 418 人开始时间: 2024年10月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 418
- 试验地点
- 8
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is an interventional, 36-week, multi-national, multi-centre, randomised, 11-armed, dosefinding,
phase 2 study. The study will be double-blinded within dose level of once weekly (QW)
subcutaneously (s.c.) administered NNC0519-0130 and the corresponding volume-matched placebo
arms. The active comparator arm with tirzepatide will be open label
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Female of non-childbearing potential, or male.
- •2.Age 18-75 years (both inclusive) at the time of signing the informed consent.
- •3.Diagnosed with type 2 diabetes mellitus more than or equal to 180 days before screening.
- •4.Stable daily dose(s) more than or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
- •5.HbA1c of 7.5-10.0 percent (58-86 mmol per mol) (both inclusive) as assessed by central laboratory at screening.
- •6.BMI more than or equal to 23.0 kg per m2.
排除标准
- •1.Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- •2.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation.
- •Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •3.Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
结局指标
主要结局
Change in HbA1c
时间窗: From baseline (week 0) to | 12 weeks on a given | maintenance dose
次要结局
- Change in body weight(From baseline (week 0) to)
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to)
- Continuous glucose(monitoring (CGM))
- Number of adverse(events)
研究者
研究点 (8)
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