A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

• Percentage of subjects with an adverse events [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
• Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
• Change from baseline in ECG [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Change from baseline in calcitonin [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
• Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

• Safety [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
• Antibodies [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: semaglutide
  0.1 mg, once weekly, s.c. injection
• Drug: semaglutide
  0.2 mg, once weekly, s.c. injection
• Drug: semaglutide
  0.4 mg, once weekly, s.c. injection
• Drug: semaglutide
  0.8 mg, once weekly, s.c. injection
• Drug: semaglutide
  0.8 mg with titration, once weekly, s.c. injection
• Drug: semaglutide
  1.6 mg with titration, once weekly, s.c. injection
• Drug: placebo
  0.1 mg, once weekly, s.c. injection
• Drug: placebo
  0.2 mg, once weekly, s.c. injection
• Drug: placebo
  0.4 mg, once weekly, s.c. injection
• Drug: placebo
  0.8 mg with titration, once weekly, s.c. injection
• Drug: placebo
  1.6 mg, once weekly, s.c. injection
• Drug: liraglutide
  1.2 mg with titration, once daily, s.c. injection
• Drug: liraglutide
  1.8 mg with titration, once daily, s.c. injection

• Experimental: A
  Intervention: Drug: semaglutide
• Experimental: B
  Intervention: Drug: semaglutide
• Experimental: C
  Intervention: Drug: semaglutide
• Experimental: D
  Intervention: Drug: semaglutide
• Experimental: E
  Intervention: Drug: semaglutide
• Experimental: F
  Intervention: Drug: semaglutide
• Placebo Comparator: G1
  Intervention: Drug: placebo
• Placebo Comparator: G2
  Intervention: Drug: placebo
• Placebo Comparator: G3
  Intervention: Drug: placebo
• Placebo Comparator: G4
  Intervention: Drug: placebo
• Placebo Comparator: G5
  Intervention: Drug: placebo
• Placebo Comparator: G6
  Intervention: Drug: placebo
• Experimental: H
  Intervention: Drug: liraglutide
• Experimental: I
  Intervention: Drug: liraglutide

Inclusion Criteria:

• Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
• Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
• HbA1c: 7.0-10.0 % (both inclusive)
• Body weight between 60 kg and 110 kg

Exclusion Criteria:

• Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
• Impaired liver or kidney function
• Proliferative retinopathy or maculopathy requiring acute treatment
• Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
• Recurrent major hypoglycaemia or hypoglycaemic unawareness
• Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)