Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 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
- 500
- 试验地点
- 257
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.
The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.
Participants will either get:
Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).
NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.
Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.
Participant must inject the study medicines themself into the stomach, thigh, or upper arm.
The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.
Women can only take part in the study if they are not able to become pregnant
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)
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
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- •Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
- •HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- •BMI greater than or equal to 25 and below 40 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 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
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
研究组 & 干预措施
2.4 mg semaglutide + 21.6 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: NNC0480-0389 (Drug)
NNC0480-0389 + placebo (semaglutide)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
干预措施: NNC0480-0389 (Drug)
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (semaglutide) (Drug)
2.4 mg semaglutide + 7.2 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: NNC0480-0389 (Drug)
NNC0480-0389 + placebo (semaglutide)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
干预措施: Placebo (semaglutide) (Drug)
2.4 mg semaglutide + 12.0 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: NNC0480-0389 (Drug)
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (NNC080-0389) (Drug)
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (NNC080-0389) (Drug)
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (NNC080-0389) (Drug)
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (semaglutide) (Drug)
2.4 mg semaglutide + 2.4 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
干预措施: NNC0480-0389 (Drug)
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (semaglutide) (Drug)
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (NNC080-0389) (Drug)
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
干预措施: Placebo (semaglutide) (Drug)
Semaglutide 2.4 mg + placebo (NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
干预措施: Placebo (NNC080-0389) (Drug)
2.4 mg semaglutide + 2.4 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
干预措施: Semaglutide (Drug)
2.4 mg semaglutide + 7.2 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: Semaglutide (Drug)
2.4 mg semaglutide + 12.0 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: Semaglutide (Drug)
2.4 mg semaglutide + 21.6 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
干预措施: Semaglutide (Drug)
Semaglutide 2.4 mg + placebo (NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From baseline (week 0) to visit 24 (week 34)
percentage-point
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
时间窗: Baseline (week 0), (week 34)
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
次要结局
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to visit 24 (week 34))
- Change in body weight (kg)(From baseline (week 0) to visit 24 (week 34))
- Relative change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to visit 24 (week 34))
- Relative change in triglycerides(From baseline (week 0) to visit 24 (week 34))
- Change in body weight (%)(From baseline (week 0) to visit 24 (week 34))
- Change in waist circumference(From baseline (week 0) to visit 24 (week 34))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to visit 24 (week 34))
- Relative change in total cholesterol(From baseline (week 0) to visit 24 (week 34))
- Relative change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to visit 24 (week 34))
- Relative change in very-low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to visit 24 (week 34))
- Relative change in Apolipoprotein B (ApoB)(From baseline (week 0) to visit 24 (week 34))
- Relative change in high sensitivity C-Reactive Protein (hsCRP)(From baseline (week 0) to visit 24 (week 34))
- Relative change in free fatty acids(From baseline (week 0) to visit 24 (week 34))
- Number of treatment-emergent adverse events (TEAEs)(From baseline (week 0) to visit 25 (week 39))
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline (week 0), (week 34))
- Change From Baseline in Body Weight (Kilogram [kg])(Baseline (week 0), (week 34))
- Percent Change From Baseline in Body Weight(Baseline (week 0), (week 34))
- Change From Baseline in Waist Circumference(Baseline (week 0), (week 34))
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline (week 0), (week 34))
- Relative Change From Baseline in Total Cholesterol - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in Triglycerides - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline(Baseline (week 0), (week 34))
- Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline(Baseline (week 0), (week 34))
- Number of Treatment-Emergent Adverse Events (TEAEs)(Baseline (week 0) to (week 39))