2023-509412-28-00已完成2 期
Safety and efficacy of once-weekly subcutaneous and once-daily oral NNC0487-0111 in participants with type 2 diabetes – a dose finding study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 59
- 主要终点
- Change in HbA1c
研究概览
简要总结
To demonstrate and characterise the dose response relationship of QW s.c. NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.
To demonstrate and characterise the dose response relationship of QD oral NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 ≥ 180 days before screening.
- •Stable daily dose(s) ≥ 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% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
- •Body mass index between ≥ 23.0 and <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 question4.
研究组 & 干预措施
METFORMIN , DAPAGLIFLOZIN
Auxiliary
干预措施: METFORMIN (Drug)
METFORMIN , DAPAGLIFLOZIN
Auxiliary
干预措施: DAPAGLIFLOZIN (Drug)
NNC0487-0111, NNC0487-0111
Test
干预措施: NNC0487-0111 (Drug)
NNC0487-0111, NNC0487-0111, NNC0487-0111, NNC0487-0111, NNC0487-0111, NNC0487-0111
Test
干预措施: NNC0487-0111 (Drug)
Placebo C tablets
Placebo
干预措施: Placebo C tablets (Drug)
Placebo A
Placebo
干预措施: Placebo A (Drug)
结局指标
主要结局
Change in HbA1c
Change in HbA1c
次要结局
- Change in body mass index (BMI)
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in average 24 hour systolic blood pressure (SBP)
- Change in high sensitivity C-Reactive Protein (hsCRP)
- Change in total cholesterol
- Change in high-density lipoprotein (HDL) cholesterol
- Change in low-density lipoprotein (LDL) cholesterol
- Change in triglycerides
- Number of adverse events
- Change in Urinary Albumin/Creatinine Ratio (UACR)
- Relative change in body weight
- Change in body weight
- Change in fasting plasma glucose (FPG)
- CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL)
- Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)
- Change in eGFR creatinine-cystatin C based CKD-EPI
研究者
EU submission Hub
Scientific
Novo Nordisk A/S
研究点 (59)
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