Phase 3 · Liraglutide

DUAL VI trial results

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

Change From Baseline in HbA1c (percentage), Week 0, week 32. IDegLira (1WT): -2.01; IDegLira: -2.02.

Participants
420
Status
completed
Completed
2015-12-23
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02298192), updated at source May 23, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What DUAL VI measured first

Change From Baseline in HbA1cpercentage · Week 0, week 32 · mean
IDegLira (1WT)n=189IDegLiran=200
-2.01(1.09)-2.02(0.98)
Side effects by arm

Side effects in DUAL VI

Percent of participants affected, Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36). The most common events the registry lists.

EventIDegLira (1WT)IDegLira
Any serious event3.3%6.7%
Nasopharyngitis6.2%4.3%
Nausea5.3%5.2%
Secondary outcomes

What else it measured

HbA1c Below 7.0%participants · Week 0, week 32 · number
MeasureIDegLira (1WT)n=189IDegLiran=200
yes170179
No1921
HbA1c Below or Equal to 6.5%particpants · Week 0, week 32 · number
MeasureIDegLira (1WT)n=189IDegLiran=200
yes158170
No3130
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesNumber of episodes · Week 0-32 · number
IDegLira (1WT)n=209IDegLiran=210
2097
The trial

How DUAL VI was run

This trial is conducted in Europe, North America and the United States of America. The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

  • Once weekly titration
  • Twice weekly titration
Who could join the trial

Inclusion Criteria: * Type 2 diabetes mellitus * Male or female equal to or above 18 years of age * HbA1c (glycosylated haemoglobin) 7.0 - 10.0% \[53 mmol/mol - 86 mmol/mol\] (both inclusive), confirmed by the central laboratory * Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening * Body Mass Index (BMI) below or equal to 40 kg/m\^2 Exclusion Criteria: * Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids) * Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator) * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit * Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR) * Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin * Screening calcitonin above or equal to 50 ng/L * Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) * History of pancreatitis (acute or chronic)

Published papers

Papers from DUAL VI

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.