Efficacy and Safety of First Line Use of Oral Semaglutide 25 mg or 50 mg Once Daily Versus Empagliflozin 25 mg or Versus Metformin 2000 mg in Newly Diagnosed Treatment naïve Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 100
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
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
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Age ≥18 and <60 years at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening.
- •HbA1c of 7.0-10.0% (53-86 millimoles per mole [mmol/mol])
- •Body mass index ≥25.0 kilogram per square meter (kg/m^2)
排除标准
- •Treatment with any medication for the indication of diabetes. Prior insulin treatment for gestational diabetes is allowed.
- •Treatment with any medication for the indication of weight management 90 days prior to screening.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 meter sqaure (mL/min/1.73 m^2) at screening.
- •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.
- •C-peptide <1.5 nanograms per milliliter (ng/mL) at screening.
- •Positive insulinoma associated-protein 2 (IA-2) antibodies ≥7.5 Units/mL or anti-glutamic acid decarboxylase (anti-GAD) antibodies greater than (>) 5.0 international units per milliliter (IU/mL).
- •Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin >1.5 times upper normal limit at screening.
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
- •Presence of clinically significant gastrointestinal disorders affecting absorption of drugs and/or nutrients, as judged by the investigator.
- •Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion
研究组 & 干预措施
Semaglutide 25 mg
Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.
干预措施: Semaglutide (Drug)
Semaglutide 50 mg
Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.
干预措施: Semaglutide (Drug)
Empagliflozin 25 mg
Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.
干预措施: Empagliflozin (Drug)
Metformin 2000 mg
Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From randomisation (week 0) to week 52
Measured in Percentage (%)-points.
次要结局
- Change in FPG(From randomisation (week 0) to week 104)
- Relative change in body weight(From randomisation (week 0) to week 104)
- Change in body weight(From randomisation (week 0) to week 104)
- HbA1c less than or equal to (≤) 6.5% (Yes/No)(At week 52)
- HbA1c less than (<) 7% (Yes/No)(At week 52)
- Change in 7 point self measured plasma glucose (SMPG) mean profile(From randomisation (week 0) to week 52)
- Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments(From randomisation (week 0) to week 52)
- Change in diastolic blood pressure(From randomisation (week 0) to week 104)
- Change in waist circumference(From randomisation (week 0) to week 104)
- HbA1c <7.0% and body weight reduction ≥5% (Yes/No)(At week 104)
- Body weight reduction greater than equal to ( ≥) 5% (Yes/No)(At week 52)
- Change in fasting plasma glucose (FPG)(From randomisation (week 0) to week 52)
- Body weight reduction ≥10% (Yes/No)(At week 104)
- Body weight reduction ≥15% (Yes/No)(At week 104)
- Change in systolic blood pressure(From randomisation (week 0) to week 104)
- Change in High-sensitivity C-reactive protein (hsCRP)(From randomisation (week 0) to week 52)
- Time to rescue medication(From randomisation (week 0) to week 104)
- Change in HbA1c(From randomisation (week 0) to week 104)
- Change in 7 point SMPG mean profile(From randomisation (week 0) to week 104)
- Change in 7-point SMPG mean post prandial increments(From randomisation (week 0) to week 104)
- HbA1c ≤6.5% (Yes/No)(At week 104)
- HbA1c <7.0% (Yes/No)(At week 104)
- Body weight reduction ≥5% (Yes/No)(At week 104)
- Change in hsCRP(From randomisation (week 0) to week 104)
- Treatment emergent adverse events(From randomisation (week 0) to follow-up visit (week 109))
- Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes(From randomisation (week 0) to follow-up visit (week 109))
- Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain(From randomisation (week 0) to week 52)
- Change in CoEQ score - Craving for Savory domain(From randomisation (week 0) to week 104)
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain(From randomisation (week 0) to week 52)
- Change in American Heart Association (AHA) Life's Simple 7 summary score(From randomisation (week 0) to week 52)
- Change in CoEQ score - Craving Control domain(From randomisation (week 0) to week 104)
- Change in IWQOL-Lite-CT score - Physical function domain(From randomisation (week 0) to week 104)
- Change in AHA Life's Simple 7 summary score(From randomisation (week 0) to week 104)