This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,089
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Change in HbA1c From Baseline
Change in HbA1c from baseline to week 30.
Time frame: Week 0, week 30
Change in Body Weight From Baseline
Change in body weight from baseline to week 30.
Time frame: Week 0, week 30
Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline to week 30.
Time frame: Week 0, week 30
Change in Diastolic Blood Pressure.
Change in diastolic blood pressure from baseline to week 30.
Time frame: Week 0, week 30
Change in Systolic Blood Pressure.
Change in systolic blood pressure from baseline to week 30.
Time frame: Week 0, week 30
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Time frame: Week 0, week 30
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Ozark, Alabama, United States
Novo Nordisk Investigational Site
Tuscumbia, Alabama, United States
Novo Nordisk Investigational Site
Gilbert, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Carmichael, California, United States
Novo Nordisk Investigational Site
Chula Vista, California, United States
Novo Nordisk Investigational Site
Elk Grove, California, United States
...and 221 more locations
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured 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. The values displayed are the estimated mean change from baseline to week 30.
Time frame: Week 0, week 30
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
Time frame: After 30 weeks treatment