Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity and type 2 diabetes

ovo Nordisk A/S0 个研究点目标入组 1,200 人开始时间: 2018年2月16日最近更新: 2021年5月3日

研究概览

暂无简介。

•- Male or female, age = 18 years at the time of signing informed consent.
•- Body Mass Index (BMI) = 27 kg/sqm
•- History of at least one self-reported unsuccessful dietary effort to lose body weight
•- Diagnosed with T2D (HbA1c 7-10% (53-86 mmol/mol) (both inclusive)) = 180 days prior to the day of screening
•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 960
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
•- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 mL/min/1.73 sqm (< 60 ml/min/1.73 sqm in subjects treated with SGLT2i ) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
•- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a
•pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

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