Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes (LIRA-LIXI™)

December 15, 2016 updated by: Novo Nordisk A/S
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • Novo Nordisk Investigational Site
      • Mlada Boleslav, Czech Republic, 293 50
        • Novo Nordisk Investigational Site
      • Olomouc, Czech Republic, 77900
        • Novo Nordisk Investigational Site
      • Plzen, Czech Republic, 32600
        • Novo Nordisk Investigational Site
      • Prostejov, Czech Republic, 79601
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00260
        • Novo Nordisk Investigational Site
      • Jyväskylä, Finland, 40100
        • Novo Nordisk Investigational Site
      • Oulu, Finland, FI-90220
        • Novo Nordisk Investigational Site
      • Pori, Finland, FI-28120
        • Novo Nordisk Investigational Site
      • Rovaniemi, Finland, 96400
        • Novo Nordisk Investigational Site
  • France
      • Boulogne Billancourt, France, 92100
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • Hinx, France, 40180
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67000
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13055
        • Novo Nordisk Investigational Site
      • Bochum, Germany, 44869
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Lampertheim, Germany, 68623
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
  • Hungary
      • Baja, Hungary, 6500
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1125
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1042
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1089
        • Novo Nordisk Investigational Site
      • Gyula, Hungary, 5700
        • Novo Nordisk Investigational Site
      • Pécs, Hungary, 7623
        • Novo Nordisk Investigational Site
      • Salgótarján, Hungary, 3100
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6720
        • Novo Nordisk Investigational Site
  • Italy
      • Catania, Italy, 95122
        • Novo Nordisk Investigational Site
      • Cittadella (PD), Italy, 35013
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35143
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 90129
        • Novo Nordisk Investigational Site
      • Terni, Italy, 05100
        • Novo Nordisk Investigational Site
  • Latvia
      • Ogre, Latvia, LV-5001
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1002
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1024
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1038
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1012
        • Novo Nordisk Investigational Site
  • Lithuania
      • Kaunas, Lithuania, 48259
        • Novo Nordisk Investigational Site
      • Kaunas, Lithuania, 50009
        • Novo Nordisk Investigational Site
      • Klaipeda, Lithuania, 94198
        • Novo Nordisk Investigational Site
      • Siauliai, Lithuania, 76231
        • Novo Nordisk Investigational Site
      • Vilnius, Lithuania, 08661
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9GT
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Chester, United Kingdom, CH2 1UL
        • Novo Nordisk Investigational Site
      • Chiswick, United Kingdom, W4 3JL
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk Investigational Site
      • Derby, United Kingdom, DE22 3NE
        • Novo Nordisk Investigational Site
      • Devon, United Kingdom, EX2 5DW
        • Novo Nordisk Investigational Site
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Novo Nordisk Investigational Site
      • Lancaster, United Kingdom, LA1 1RP
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL6 8BQ
        • Novo Nordisk Investigational Site
      • Sandbach, United Kingdom, CW11 1EQ
        • Novo Nordisk Investigational Site
      • Taunton, United Kingdom, TA1 5DA
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin + liraglutide 1.8 mg
Drug: 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).
Active Comparator: Metformin + lixisenatide 20 microg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline
Time Frame: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline
Time Frame: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment.
Week 0, week 26
Change in Body Weight From Baseline
Time Frame: Week 0, week 26
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)
Time Frame: After 26 weeks of treatment
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)
Time Frame: After 26 weeks of treatment
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)
Time Frame: After 26 weeks of treatment
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)
Time Frame: Weeks 0-26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3867
  • 2012-004984-27 (EudraCT Number)
  • U1111-1136-3644 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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