Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in subjects with type 2 diabetes - PIONEER PLUS

ovo Nordisk A/S0 个研究点目标入组 1,224 人开始时间: 2021年1月22日最近更新: 2021年4月5日

研究概览

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•- Male or female, age above or equal to 18 years at the time of signing informed consent.
•- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
•- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
•- Body Mass Index (BMI) equal to or above 25 kg/m^2
•- Stable daily dose(s) for 90 days prior to the day of screening of: any of the following treatment regimens:
•- No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
•1. * Metformin (equal to or above 1500 mg or maximum tolerated or effective dose).
•2. * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
•3. * Sodium-glucose co-transporter 2 (SGLT2) inhibitors (maximum tolerated dose).
•4. Dipeptyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
•- Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to terminate DPP-4 inhibitor treatment at randomisation (with no wash-out).
•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 970
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 254

•- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
•- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification.
•- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.

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