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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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