NCT05444153撤回3 期
Efficacy and Safety of Early Initiation of Oral Semaglutide 50 mg Once Daily Versus Empagliflozin 25 mg Once Daily in Younger Patients With Newly Diagnosed Type 2 Diabetes and Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)
研究概览
简要总结
This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18- less than (<) 50 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus less than or equal to (<=) 365 days from the day of screening.
- •Glycated haemoglobin (HbA1c) of 7.0-9.5 percentage (%) (53-80 millimoles per milliliter [mmol/mol]) (both inclusive).
- •Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per meter square (kg/m^2).
- •Treatment naïve to any antidiabetic drug(s). However, for a subset of participants (≤25%) any metformin dose or formulations administered is allowed.
排除标准
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria since diagnosed with type 2 diabetes mellitus. Prior insulin treatment for gestational diabetes is allowed.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 60 milliliter per minute per 1.73 meter square (1.7mL/min/1.73 m^2) at screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.
- •C-peptide less than (<)1.5 nanograms per milliliter (ng/mL) at screening.
- •Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
- •History of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients.
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
研究组 & 干预措施
Oral semaglutide
Experimental
Participants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks.
干预措施: Semaglutide (Drug)
Empagliflozin
Active Comparator
Participants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks.
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)
时间窗: At week 104
Measured as count of participants.
Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)
时间窗: At week 104
Measured as count of participants.
次要结局
- Change in HbA1c(From randomisation (week 0) to week 104)
- Change in fasting plasma glucose (FPG)(From randomisation (week 0) to week 104)
- Change in self-measured plasma glucose (SPMG) 7-point mean profile(From randomisation (week 0) to week 104)
- Change in self-measured plasma glucose (SPMG) mean post prandial increments(From randomisation (week 0) to week 104)
- Time to additional anti-diabetic medication(From randomisation (week 0) to week 104)
- Relative change in body weight(From randomisation (week 0) to week 104)
- Change in waist circumference(From randomisation (week 0) to week 104)
- Change in body weight(From randomisation (week 0) to week 104)
- Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)(From randomisation (week 0) to week 104)
- Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)(From randomisation (week 0) to week 104)
- Change in systolic blood pressure(From randomisation (week 0) to week 104)
- Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)(From randomisation (week 0) to week 104)
- Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain(From randomisation (week 0) to week 104)
- Change in high density lipoprotein (HDL)(From randomisation (week 0) to week 104)
- Change in low density lipoprotein (LDL)(From randomisation (week 0) to week 104)
- Change in very low density lipoprotein (VLDL)(From randomisation (week 0) to week 104)
- Change in total cholesterol(From randomisation (week 0) to week 104)
- Change in Triglycerides(From randomisation (week 0) to week 104)
- Change in free fatty acids(From randomisation (week 0) to week 104)
- Number of treatment emergent adverse events(From randomisation (week 0) to week 109)
- Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina(From randomisation (week 0) to week 104)
研究者
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