This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
813
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Mean change in HbA1c from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Body Weight
Mean change in body weight from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change in FPG from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Time frame: Week 0, week 56
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
Time frame: Week 0, week 56
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
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Novo Nordisk Investigational Site
Anniston, Alabama, United States
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Pell City, Alabama, United States
Novo Nordisk Investigational Site
Glendale, Arizona, United States
Novo Nordisk Investigational Site
Mesa, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Burbank, California, United States
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States
Novo Nordisk Investigational Site
Lomita, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
...and 136 more locations
Time frame: After 56 weeks' treatment