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

NCT ID: NCT00696657

Last Updated: 2019-08-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-03

Study Completion Date

2009-02-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

0.1 mg, once weekly, s.c. injection

B

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

0.2 mg, once weekly, s.c. injection

C

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

0.4 mg, once weekly, s.c. injection

D

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

0.8 mg, once weekly, s.c. injection

E

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

0.8 mg with titration, once weekly, s.c. injection

F

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

1.6 mg with titration, once weekly, s.c. injection

G1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.1 mg, once weekly, s.c. injection

G2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.2 mg, once weekly, s.c. injection

G3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.4 mg, once weekly, s.c. injection

G4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.8 mg with titration, once weekly, s.c. injection

G5

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.8 mg with titration, once weekly, s.c. injection

G6

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1.6 mg, once weekly, s.c. injection

H

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

1.2 mg with titration, once daily, s.c. injection

I

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

1.8 mg with titration, once daily, s.c. injection

Interventions

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semaglutide

0.1 mg, once weekly, s.c. injection

Intervention Type DRUG

semaglutide

0.2 mg, once weekly, s.c. injection

Intervention Type DRUG

semaglutide

0.4 mg, once weekly, s.c. injection

Intervention Type DRUG

semaglutide

0.8 mg, once weekly, s.c. injection

Intervention Type DRUG

semaglutide

0.8 mg with titration, once weekly, s.c. injection

Intervention Type DRUG

semaglutide

1.6 mg with titration, once weekly, s.c. injection

Intervention Type DRUG

placebo

0.1 mg, once weekly, s.c. injection

Intervention Type DRUG

placebo

0.2 mg, once weekly, s.c. injection

Intervention Type DRUG

placebo

0.4 mg, once weekly, s.c. injection

Intervention Type DRUG

placebo

0.8 mg with titration, once weekly, s.c. injection

Intervention Type DRUG

placebo

1.6 mg, once weekly, s.c. injection

Intervention Type DRUG

liraglutide

1.2 mg with titration, once daily, s.c. injection

Intervention Type DRUG

liraglutide

1.8 mg with titration, once daily, s.c. injection

Intervention Type DRUG

Other Intervention Names

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NN9535 NN9535 NN9535 NN9535 NN9535 NN9535

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry B. (GCR, 1452), MD, PhD

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Gratwein, , Austria

Site Status

Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Innsbruck, , Austria

Site Status

Novo Nordisk Investigational Site

Mödling, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Plovdiv, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Rousse, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Varna, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Imatra, , Finland

Site Status

Novo Nordisk Investigational Site

Mikkeli, , Finland

Site Status

Novo Nordisk Investigational Site

Oulu, , Finland

Site Status

Novo Nordisk Investigational Site

Tampere, , Finland

Site Status

Novo Nordisk Investigational Site

Turku, , Finland

Site Status

Novo Nordisk Investigational Site

Dommartin-lès-Toul, , France

Site Status

Novo Nordisk Investigational Site

La Rochelle, , France

Site Status

Novo Nordisk Investigational Site

Montpellier, , France

Site Status

Novo Nordisk Investigational Site

Narbonne, , France

Site Status

Novo Nordisk Investigational Site

Vénissieux, , France

Site Status

Novo Nordisk Investigational Site

Bad Lauterberg im Harz, , Germany

Site Status

Novo Nordisk Investigational Site

Falkensee, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Ludwigshafen, , Germany

Site Status

Novo Nordisk Investigational Site

Marburg, , Germany

Site Status

Novo Nordisk Investigational Site

Münster, , Germany

Site Status

Novo Nordisk Investigational Site

Pohlheim, , Germany

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Debrecen, , Hungary

Site Status

Novo Nordisk Investigational Site

Gyula, , Hungary

Site Status

Novo Nordisk Investigational Site

Pécs, , Hungary

Site Status

Novo Nordisk Investigational Site

Szekszárd, , Hungary

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, , India

Site Status

Novo Nordisk Investigational Site

Hyderabad, , India

Site Status

Novo Nordisk Investigational Site

Catanzaro, , Italy

Site Status

Novo Nordisk Investigational Site

Chieti, , Italy

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Milano (MI), , Italy

Site Status

Novo Nordisk Investigational Site

Napoli, , Italy

Site Status

Novo Nordisk Investigational Site

Perugia, , Italy

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia and Montenegro

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Novo Nordisk Investigational Site

Almería, , Spain

Site Status

Novo Nordisk Investigational Site

Gijón, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Bern, , Switzerland

Site Status

Novo Nordisk Investigational Site

Geneva, , Switzerland

Site Status

Novo Nordisk Investigational Site

Lausanne, , Switzerland

Site Status

Novo Nordisk Investigational Site

Sankt Gallen, , Switzerland

Site Status

Novo Nordisk Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Addlestone, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bath, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bexhill-on-Sea, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bradford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Dundee, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Guildford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Hull, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Inverness, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Llanelli, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Trowbridge, , United Kingdom

Site Status

Countries

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

References

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Nauck MA, Petrie JR, Sesti G, Mannucci E, Courreges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

Reference Type DERIVED
PMID: 26358288 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2007-003956-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9535-1821

Identifier Type: -

Identifier Source: org_study_id

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