Clinical trial NCT01973231: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-10-31
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

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)
* Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness
* 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)

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline
timeFrame: Week 0, week 26
measure: Change in Body Weight From Baseline
timeFrame: Week 0, week 26
measure: Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
timeFrame: After 26 weeks of treatment
measure: Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)
timeFrame: After 26 weeks of treatment
measure: Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)
timeFrame: After 26 weeks of treatment
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Weeks 0-26
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Mlada Boleslav
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Plzen
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Prostejov
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Jyväskylä
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Pori
country: Finland
facility: Novo Nordisk Investigational Site
city: Rovaniemi
country: Finland
facility: Novo Nordisk Investigational Site
city: Boulogne Billancourt
country: France
facility: Novo Nordisk Investigational Site
city: Corbeil Essonnes
country: France
facility: Novo Nordisk Investigational Site
city: Hinx
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Saint Herblain
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bochum
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Lampertheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Baja
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Gyula
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pécs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Salgótarján
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szeged
country: Hungary
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Cittadella (PD)
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Terni
country: Italy
facility: Novo Nordisk Investigational Site
city: Ogre
country: Latvia
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Kaunas
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Kaunas
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Klaipeda
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Siauliai
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Vilnius
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Basingstoke
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chiswick
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Devon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Great Yarmouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Lancaster
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sandbach
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Taunton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.