Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name LIRA-LIXI™

NCTNCT01973231 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3867Other id2012-004984-27Other idU1111-1136-3644
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
404 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
9 countries

Czechia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, United Kingdom

Start
Oct 2013
Primary completion
Nov 2014
Completion
Nov 2014
First posted
31 Oct 2013 (estimated)
Last update posted
9 Feb 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

    LIRA-LIXI™

    NCT01973231

    Oct 2013 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • lixisenatideDrug

Arms2

  • Experimental

    Metformin + liraglutide 1.8 mg

  • Active comparator

    Metformin + lixisenatide 20 microg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Haemoglobin (HbA1c) From Baseline

    Time frame · Week 0, week 26

    Registry description

    Change from baseline in HbA1c after 26 weeks of treatment.

Secondary outcomes(6)

  1. Change in Fasting Plasma Glucose (FPG) From Baseline

    Time frame · Week 0, week 26

    Registry description

    Change from baseline in FPG after 26 weeks of treatment.

  2. Change in Body Weight From Baseline

    Time frame · Week 0, week 26

    Registry description

    Change from baseline in body weight after 26 weeks of treatment.

  3. Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

    Time frame · After 26 weeks of treatment

    Registry description

    Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).

  4. 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

    Registry description

    Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).

  5. Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)

    Time frame · After 26 weeks of treatment

    Registry description

    Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).

  6. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame · Weeks 0-26

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 26

Change in Glycosylated Haemoglobin (HbA1c) From Baseline

GroupValue (Percent (%) glycosylated haemoglobin)Spread
Liraglutide-1.8090.9159
Lixisenatide-1.2381.0085
Secondary and other outcome results(6)
Secondary outcomeMean· Week 0, week 26

Change in Fasting Plasma Glucose (FPG) From Baseline

GroupValue (mmol/L)Spread
Liraglutide-2.9042.2309
Lixisenatide-1.6442.1511
Secondary outcomeMean· Week 0, week 26

Change in Body Weight From Baseline

GroupValue (kg)Spread
Liraglutide-4.244.273
Lixisenatide-3.694.746
Secondary outcomeNumber· After 26 weeks of treatment

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

GroupValue (percentage (%) of subjects)
Liraglutide74.2
Lixisenatide45.5
Secondary outcomeNumber· 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)

GroupValue (percentage (%) of subjects)
Liraglutide54.6
Lixisenatide26.2
Secondary outcomeNumber· After 26 weeks of treatment

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)

GroupValue (percentage (%) of subjects)
Liraglutide66.5
Lixisenatide41.9
Secondary outcomeNumber· Weeks 0-26

Number of Treatment Emergent Adverse Events (TEAEs)

GroupValue (events)
Liraglutide540
Lixisenatide435

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideLiraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.–12 / 20290 / 202
LixisenatideLixisenatide was 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 (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.–7 / 20283 / 202

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Observational study · 2017

5 results

Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting.

Hunt et al. 2017Diabetes, obesity & metabolismcited by 17

PMID 28124820DOI 10.1111/dom.12890PUB-28124820

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2016

25 results

Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial.

Nauck et al. 2016Diabetes carecited by 94

PMID 27311491DOI 10.2337/dc15-2479PUB-27311491

Full text at the publisher25 results
Publisher pageSee results (25)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

PepBank is a research reference. Talk to a doctor before you use any peptide.