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Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

NCT ID: NCT01973231

Last Updated: 2017-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).

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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

NONE

Study Groups

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Metformin + liraglutide 1.8 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).

Metformin + lixisenatide 20 microg

Group Type ACTIVE_COMPARATOR

lixisenatide

Intervention Type DRUG

Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

Interventions

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liraglutide

Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).

Intervention Type DRUG

lixisenatide

Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
* HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
* Body Mass Index (BMI) equal to or above 20 kg/m\^2

* History of chronic pancreatitis or idiopathic acute pancreatitis
* Screening calcitonin value equal to or above 50 ng/L
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 per Modification of Diet in Renal Disease (MDRD) formula
* Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
* Heart failure, New York Heart Association (NYHA) class IV
* Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Exclusion Criteria

* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice)
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 (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Hradec Králové, , Czechia

Site Status

Novo Nordisk Investigational Site

Mladá Boleslav, , Czechia

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Pilsen, , Czechia

Site Status

Novo Nordisk Investigational Site

Prostějov, , Czechia

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Jyväskylä, , Finland

Site Status

Novo Nordisk Investigational Site

Oulu, , Finland

Site Status

Novo Nordisk Investigational Site

Pori, , Finland

Site Status

Novo Nordisk Investigational Site

Rovaniemi, , Finland

Site Status

Novo Nordisk Investigational Site

Boulogne-Billancourt, , France

Site Status

Novo Nordisk Investigational Site

Corbeil-Essonnes, , France

Site Status

Novo Nordisk Investigational Site

Hinx, , France

Site Status

Novo Nordisk Investigational Site

La Rochelle, , France

Site Status

Novo Nordisk Investigational Site

Saint-Herblain, , France

Site Status

Novo Nordisk Investigational Site

Strasbourg, , 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

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Bochum, , Germany

Site Status

Novo Nordisk Investigational Site

Dresden, , Germany

Site Status

Novo Nordisk Investigational Site

Duisburg, , Germany

Site Status

Novo Nordisk Investigational Site

Friedrichsthal, , Germany

Site Status

Novo Nordisk Investigational Site

Lampertheim, , Germany

Site Status

Novo Nordisk Investigational Site

Ludwigshafen, , Germany

Site Status

Novo Nordisk Investigational Site

Saint Ingbert, , Germany

Site Status

Novo Nordisk Investigational Site

Baja, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Gyula, , Hungary

Site Status

Novo Nordisk Investigational Site

Pécs, , Hungary

Site Status

Novo Nordisk Investigational Site

Salgótarján, , Hungary

Site Status

Novo Nordisk Investigational Site

Szeged, , Hungary

Site Status

Novo Nordisk Investigational Site

Catania, , Italy

Site Status

Novo Nordisk Investigational Site

Cittadella (PD), , Italy

Site Status

Novo Nordisk Investigational Site

Padua, , Italy

Site Status

Novo Nordisk Investigational Site

Palermo, , Italy

Site Status

Novo Nordisk Investigational Site

Terni, , Italy

Site Status

Novo Nordisk Investigational Site

Ogre, , Latvia

Site Status

Novo Nordisk Investigational Site

Riga, , Latvia

Site Status

Novo Nordisk Investigational Site

Riga, , Latvia

Site Status

Novo Nordisk Investigational Site

Riga, , Latvia

Site Status

Novo Nordisk Investigational Site

Riga, , Latvia

Site Status

Novo Nordisk Investigational Site

Kaunas, , Lithuania

Site Status

Novo Nordisk Investigational Site

Kaunas, , Lithuania

Site Status

Novo Nordisk Investigational Site

Klaipėda, , Lithuania

Site Status

Novo Nordisk Investigational Site

Šiauliai, , Lithuania

Site Status

Novo Nordisk Investigational Site

Vilnius, , Lithuania

Site Status

Novo Nordisk Investigational Site

Basingstoke, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bristol, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Chester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Chiswick, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Coventry, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Derby, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Devon, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Great Yarmouth, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Lancaster, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Plymouth, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sandbach, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Taunton, , United Kingdom

Site Status

Countries

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Czechia Finland France Germany Hungary Italy Latvia Lithuania United Kingdom

References

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Nauck M, Rizzo M, Johnson A, Bosch-Traberg H, Madsen J, Cariou B. Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial. Diabetes Care. 2016 Sep;39(9):1501-9. doi: 10.2337/dc15-2479. Epub 2016 Jun 16.

Reference Type RESULT
PMID: 27311491 (View on PubMed)

Hunt B, Vega-Hernandez G, Valentine WJ, Kragh N. Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting. Diabetes Obes Metab. 2017 Jun;19(6):842-849. doi: 10.1111/dom.12890. Epub 2017 Feb 23.

Reference Type DERIVED
PMID: 28124820 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004984-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1136-3644

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3867

Identifier Type: -

Identifier Source: org_study_id

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