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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DUAL™ VI

NCTNCT02298192 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4056Other id2012-004625-25Other idU1111-1135-6634
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
420 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
9 countries

United States, Austria, Bulgaria, Canada, Czechia, Hungary, Russia, Serbia, Slovakia

Start
21 Nov 2014
Primary completion
23 Dec 2015
Completion
23 Dec 2015
First posted
21 Nov 2014 (estimated)
Last update posted
23 May 2017
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
201420152016
  1. Ph 3

    DUAL™ VI

    NCT02298192

    21 Nov 2014 to 23 Dec 2015

Registry summary

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

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.

Interventions

  • insulin degludec/liraglutideDrug

Arms2

  • Experimental

    Once weekly titration

  • Experimental

    Twice weekly titration

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c

    Time frame · Week 0, week 32

    Registry description

    Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.

Secondary outcomes(3)

  1. HbA1c Below 7.0%

    Time frame · Week 0, week 32

    Registry description

    Responders to HbA1c below 7% after 32 weeks of treatment.

  2. HbA1c Below or Equal to 6.5%

    Time frame · Week 0, week 32

    Registry description

    Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.

  3. Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

    Time frame · Week 0-32

    Registry description

    An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

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 32

Change From Baseline in HbA1c

GroupValue (percentage)Spread
IDegLira (1WT)-2.011.09
IDegLira-2.020.98
Secondary and other outcome results(3)
Secondary outcomeNumber· Week 0, week 32

HbA1c Below 7.0%

GroupValue (participants)
IDegLira (1WT)170
IDegLira179
Secondary outcomeNumber· Week 0, week 32

HbA1c Below or Equal to 6.5%

GroupValue (particpants)
IDegLira (1WT)158
IDegLira170
Secondary outcomeNumber· Week 0-32

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

GroupValue (Number of episodes)
IDegLira (1WT)20
IDegLira97

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IDegLira (1WT)Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.–7 / 20924 / 209
IDegLiraSubjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.–14 / 21019 / 210

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 · 2017

8 results

Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial.

Harris et al. 2017Diabetes, obesity & metabolismcited by 50

PMID 28124817PMC5484356DOI 10.1111/dom.12892PUB-28124817

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultSafety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016

Eligibility

Who could join, as posted.

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

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