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

Summary

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.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Global Clinical Registry B. (GCR, 1452), MD, PhD · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-03

Primary Completion

2009-02-05

Completion

2009-02-05

Countries

• Austria
• Bulgaria
• Finland
• France
• Germany
• Hungary
• India
• Italy
• Serbia and Montenegro
• South Africa
• Spain
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations