This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
Novo Nordisk Investigational Site
Buena Park, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
San Jose, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Troy, Michigan, United States
Novo Nordisk Investigational Site
Albany, New York, United States
...and 15 more locations
Change in glycosylated haemoglobin (HbA1c)
Percent-point
Time frame: From baseline (week 0) to week 12
Change in fasting plasma glucose
mmol/L
Time frame: From baseline (week 0) to week 12
Change in body weight
Kg
Time frame: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Count
Time frame: From baseline (week 0) to week 12
Number of treatment emergent gastrointestinal adverse events
Count
Time frame: From baseline (week 0) to week 12
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Count
Time frame: From baseline (week 0) to week 12
Change in pulse rate
Beats per minute (bpm)
Time frame: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Count
Time frame: From week 12 to week 17
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