Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 217
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
- •Stable daily dose(s) greater 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.
- •HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
- •Body mass index between greater or equal to 23.0 and below 50.0 kg/m^
- •Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.
排除标准
- •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.
- •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.
- •Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
研究组 & 干预措施
NNC0487-0111 subcutaneous dose 5
NNC0487-0111 subcutaneous dose 5 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
Placebo subcutaneous
Placebo for subcutaneous treatment
干预措施: Placebo (NNC0487-0111 subcutanous) (Drug)
NNC0487-0111 subcutaneous dose 1
NNC0487-0111 subcutaneous dose 1 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
NNC0487-0111 subcutaneous dose 2
NNC0487-0111 subcutaneous dose 2 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
NNC0487-0111 subcutaneous dose 3
NNC0487-0111 subcutaneous dose 3 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
NNC0487-0111 subcutaneous dose 4
NNC0487-0111 subcutaneous dose 4 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
NNC0487-0111 subcutaneous dose 6
NNC0487-0111 subcutaneous dose 6 treatment
干预措施: NNC0487-0111 subcutanous (Drug)
Placebo oral
Placebo for oral treatment
干预措施: Placebo (NNC0487-0111 oral) (Drug)
NNC0487-0111 oral dose 1
NNC0487-0111 oral dose 1 treatment
干预措施: NNC0487-0111 oral (Drug)
NNC0487-0111 oral dose 2
NNC0487-0111 oral dose 2 treatment
干预措施: NNC0487-0111 oral (Drug)
NNC0487-0111 oral dose 3
NNC0487-0111 oral dose 3 treatment
干预措施: NNC0487-0111 oral (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From baseline (week 0) to end of treatment (week 36)
percent point
次要结局
- Change in waist circumference(From baseline (week 0) to end of treatment (week 36))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 36))
- Change in average 24-hour systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 36))
- Change in high sensitivity C-Reactive Protein (hsCRP)(From baseline (week 0) to end of treatment (week 36))
- Relative change in body weight(From baseline (week 0) to end of treatment (week 36))
- Change in body weight(From baseline (week 0) to end of treatment (week 36))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to end of treatment (week 36))
- CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)(From baseline (week 0) to end of treatment (week 36))
- Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 36))
- Change in total cholesterol(From baseline (week 0) to end of treatment (week 36))
- Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 36))
- Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 36))
- Change in triglycerides(From baseline (week 0) to end of treatment (week 36))
- Number of adverse events(From baseline (week 0) to end of study (week 40))
- Change in Urinary Albumin/Creatinine Ratio (UACR)(From baseline (week 0) to end of treatment (week 36))
- Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)(At end of treatment (week 36))
- Change in eGFR creatinine- and cystatin C based CKD-EPI(From baseline (week 0) to end of treatment (week 36))