Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 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
- 299
- 试验地点
- 110
- 主要终点
- Change in Glycated haemoglobin (HbA1c)
研究概览
简要总结
This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 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. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.
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
- •Female of non-childbearing potential, or male.
- •For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
- •Age 18-75 years (both inclusive) at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
- •Stable daily dose(s) more than or equal 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 sodium-glucose co-transporter 2 (SGLT2) inhibitor.
- •Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
- •Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).
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
Dosing scheme B (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
干预措施: Placebo (Drug)
Dosing scheme B (NNC0519-0130)
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.
干预措施: NNC0519-0130 (Drug)
Dosing scheme C (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
干预措施: Placebo (Drug)
Dosing scheme D (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
干预措施: Placebo (Drug)
Dosing scheme A (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
干预措施: Placebo (Drug)
Dosing scheme C (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
干预措施: NNC0519-0130 (Drug)
Dosing scheme A (NNC0519-0130)
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.
干预措施: NNC0519-0130 (Drug)
Dosing scheme E (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
干预措施: Placebo (Drug)
Dosing scheme F (tirzepatide)
Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
干预措施: Trizepatide (Drug)
Dosing scheme D (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
干预措施: NNC0519-0130 (Drug)
Dosing scheme E (NNC0519-0130)
Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
干预措施: NNC0519-0130 (Drug)
结局指标
主要结局
Change in Glycated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to 12 weeks on a given maintenance dose
Measured as percentage point (%-point)
次要结局
- 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 Glycated haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 36))
- Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))(From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively)
- 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 12 weeks on a given maintenance dose)
- 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 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))