This trial is conducted in Europe. The aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide. Each treatment period will be followed by a hypoglycaemic clamp
2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection. Each treatment period will be followed by a hypoglycaemic clamp.
Novo Nordisk Investigational Site
Graz, Austria
Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Hypoglycaemic symptoms score
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
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