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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: placebo; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696657

2007-003956-12 (EudraCT Number)

NN9535-1821

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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415 participants in 14 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

B

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

C

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

D

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

E

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

F

Experimental group

Treatment:

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

Drug: semaglutide

G1

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

G2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

G3

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

G4

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

G5

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

G6

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

H

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

I

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide