EUCTR2021-004392-13-PT进行中（未招募）1 期
Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose reduced insulin glargine vs titrated insulin glargine in participants with type 2 diabetes and overweight - (SUSTAIN OPTIMIZE)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 568
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Diagnosed with T2D mellitus greater than or equal to 180 days before screening.
- •- HbA1c of 7-9% (53-75 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •- Body mass index (BMI) greater than or equal to 25 kg/m^2 on the day of screening.
- •- Stable daily dose(s) greater than or equal to 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
- •- Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose.
- •- Any metformin combination formulation greater than or equal to 1500 mg or maximum tolerated or effective dose.
- •The treatment can be with or without SGLT-2 inhibitors.
- •- Treated with once daily insulin glargine U100 injections less than or equal to 40 units/day greater than or equal to 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 324
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 244
排除标准
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.
- •- Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.5 nmol/L (1.5 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/mL, as measured by the central laboratory at screening.
- •- Presence or history(a) of pancreatitis (acute or chronic).
- •- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification.
- •- Any episodes(a) of diabetic ketoacidosis within 90 days before screening.
- •- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
- •(a) As declared by the participant or in the medical records
研究者
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