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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

Short name LIRA-SWITCH™

NCTNCT01907854 (opens ClinicalTrials.gov in a new tab)Other idNN2211-4059Other id2012-004931-22Other idU1111-1136-2073Other idCTRI/2014/05/004623
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
407 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
7 countries

United States, Canada, Hungary, India, Israel, Puerto Rico, Spain

Start
2 Dec 2013
Primary completion
15 Jun 2015
Completion
15 Jun 2015
First posted
25 Jul 2013 (estimated)
Last update posted
2 Oct 2018
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
2013201420152016
  1. Ph 4

    LIRA-SWITCH™

    NCT01907854

    2 Dec 2013 to 15 Jun 2015

Registry summary

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

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.

Interventions

  • liraglutideDrug
  • sitagliptinDrug
  • placeboDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide + metformin + sitagliptin placebo

  • Experimental

    Sitagliptin + metformin + liraglutide placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (Glycosylated Haemoglobin)

    Time frame · From baseline to week 26

    Registry description

    Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).

Secondary outcomes(6)

  1. Change in Body Weight

    Time frame · From baseline to week 26

    Registry description

    Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.

  2. Change in Fasting Plasma Glucose

    Time frame · From baseline to week 26

    Registry description

    Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  3. Change in Fasting Blood Lipids

    Time frame · From baseline to week 26

    Registry description

    Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein \[LDL\], very low density lipoprotein \[VLDL\], high density lipoprotein \[HDL\], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.

  4. Change in Systolic Blood Pressure and Diastolic Blood Pressure

    Time frame · From baseline to week 26

    Registry description

    Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  5. Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)

    Time frame · After 26 weeks of treatment

    Registry description

    Number of subjects who achieve HbA1c \<7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  6. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame · During 26 weeks of treatment plus one week follow-up period.

    Registry description

    A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.

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· From baseline to week 26

Change in HbA1c (Glycosylated Haemoglobin)

GroupValue (percentage of glycosylated haemoglobin)Spread
Liraglutide-1.1460.9748
Sitagliptin-0.5291.0148
Secondary and other outcome results(6)
Secondary outcomeMean· From baseline to week 26

Change in Body Weight

GroupValue (kg)Spread
Liraglutide-3.323.135
Sitagliptin-1.802.974
Secondary outcomeMean· From baseline to week 26

Change in Fasting Plasma Glucose

GroupValue (nmol/L)Spread
Liraglutide-1.9672.3585
Sitagliptin-0.5882.1363
Secondary outcomeMean· From baseline to week 26

Change in Fasting Blood Lipids

GroupValue (ratio)Spread
Liraglutide1.0110.1906
Sitagliptin1.0450.2323
Secondary outcomeMean· From baseline to week 26

Change in Systolic Blood Pressure and Diastolic Blood Pressure

GroupValue (mmHg)Spread
Liraglutide-3.611.596
Sitagliptin-2.5711.593
Secondary outcomeNumber· After 26 weeks of treatment

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)

GroupValue (percentage (%))
Liraglutide50.6
Sitagliptin26.9
Secondary outcomeNumber· During 26 weeks of treatment plus one week follow-up period.

Number of Treatment Emergent Adverse Events (TEAEs)

GroupValue (number of events)
Liraglutide455
Sitagliptin318

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideSubjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD sitagliptin placebo tablets.–6 / 20296 / 202
SitagliptinSubjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.–7 / 20461 / 204

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

3 results

Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial.

Bailey et al. 2016Diabetes, obesity & metabolismcited by 30

PMID 27381275PMC5129465DOI 10.1111/dom.12736PUB-27381275

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

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 type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose * \- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive) * \- Body mass index equal to or above 20 kg/m\^2 Exclusion Criteria: * \- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol * \- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness * \- Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice) * \- 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 or multiple endocrine neoplasia syndrome type 2 * \- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * \- Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit * \- Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m\^2 per modification of diet in renal disease formula * \- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening * \- Heart failure, New York Heart Association class IV * \- Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

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