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Clinical Trial Details

Trial ID: L2143
Source ID: NCT01973231
Associated Drug: Liraglutide
Title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Acronym: LIRA-LIXI™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01973231/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: lixisenatide
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline, Change from baseline in HbA1c after 26 weeks of treatment., Week 0, week 26 | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline, Change from baseline in FPG after 26 weeks of treatment., Week 0, week 26|Change in Body Weight From Baseline, Change from baseline in body weight after 26 weeks of treatment., Week 0, week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no), Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no)., After 26 weeks of treatment|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no), Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no)., After 26 weeks of treatment|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no), Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no)., After 26 weeks of treatment|Number of Treatment Emergent Adverse Events (TEAEs), A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator., Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 404
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-10
Completion Date: 2014-11
Results First Posted: 2015-12-22
Last Update Posted: 2017-02-09
Locations: Novo Nordisk Investigational Site, Hradec Kralove, 50005, Czech Republic|Novo Nordisk Investigational Site, Mlada Boleslav, 293 50, Czech Republic|Novo Nordisk Investigational Site, Olomouc, 77900, Czech Republic|Novo Nordisk Investigational Site, Plzen, 32600, Czech Republic|Novo Nordisk Investigational Site, Prostejov, 79601, Czech Republic|Novo Nordisk Investigational Site, Helsinki, 00260, Finland|Novo Nordisk Investigational Site, Jyväskylä, 40100, Finland|Novo Nordisk Investigational Site, Oulu, FI-90220, Finland|Novo Nordisk Investigational Site, Pori, FI-28120, Finland|Novo Nordisk Investigational Site, Rovaniemi, 96400, Finland|Novo Nordisk Investigational Site, Boulogne Billancourt, 92100, France|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, Hinx, 40180, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Strasbourg, 67000, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Bad Lauterberg, 37431, Germany|Novo Nordisk Investigational Site, Berlin, 13055, Germany|Novo Nordisk Investigational Site, Bochum, 44869, Germany|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Duisburg, 47051, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Lampertheim, 68623, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Baja, 6500, Hungary|Novo Nordisk Investigational Site, Budapest, 1042, Hungary|Novo Nordisk Investigational Site, Budapest, 1089, Hungary|Novo Nordisk Investigational Site, Budapest, 1125, Hungary|Novo Nordisk Investigational Site, Gyula, 5700, Hungary|Novo Nordisk Investigational Site, Pécs, 7623, Hungary|Novo Nordisk Investigational Site, Salgótarján, 3100, Hungary|Novo Nordisk Investigational Site, Szeged, H-6720, Hungary|Novo Nordisk Investigational Site, Catania, 95122, Italy|Novo Nordisk Investigational Site, Cittadella (PD), 35013, Italy|Novo Nordisk Investigational Site, Padova, 35143, Italy|Novo Nordisk Investigational Site, Palermo, 90129, Italy|Novo Nordisk Investigational Site, Terni, 05100, Italy|Novo Nordisk Investigational Site, Ogre, LV-5001, Latvia|Novo Nordisk Investigational Site, Riga, LV-1002, Latvia|Novo Nordisk Investigational Site, Riga, LV-1012, Latvia|Novo Nordisk Investigational Site, Riga, LV-1024, Latvia|Novo Nordisk Investigational Site, Riga, LV-1038, Latvia|Novo Nordisk Investigational Site, Kaunas, 48259, Lithuania|Novo Nordisk Investigational Site, Kaunas, 50009, Lithuania|Novo Nordisk Investigational Site, Klaipeda, 94198, Lithuania|Novo Nordisk Investigational Site, Siauliai, 76231, Lithuania|Novo Nordisk Investigational Site, Vilnius, 08661, Lithuania|Novo Nordisk Investigational Site, Basingstoke, RG24 9GT, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Chester, CH2 1UL, United Kingdom|Novo Nordisk Investigational Site, Chiswick, W4 3JL, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV2 2DX, United Kingdom|Novo Nordisk Investigational Site, Derby, DE22 3NE, United Kingdom|Novo Nordisk Investigational Site, Devon, EX2 5DW, United Kingdom|Novo Nordisk Investigational Site, Great Yarmouth, NR31 6LA, United Kingdom|Novo Nordisk Investigational Site, Lancaster, LA1 1RP, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8BQ, United Kingdom|Novo Nordisk Investigational Site, Sandbach, CW11 1EQ, United Kingdom|Novo Nordisk Investigational Site, Taunton, TA1 5DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01973231

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress