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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Short name DUAL™ V

NCTNCT01952145 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3952Other id2012-004413-14Other idU1111-1135-1003
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Argentina, Australia, Greece, Hungary, Mexico, Russia, Slovakia, South Africa, Spain

Start
20 Sept 2013
Primary completion
4 Nov 2014
Completion
4 Nov 2014
First posted
27 Sept 2013 (estimated)
Last update posted
3 Jan 2019
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 3

    DUAL™ V

    NCT01952145

    20 Sept 2013 to 4 Nov 2014

Registry summary

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

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin glargineDrug

Arms2

  • Experimental

    Insulin degludec/liraglutide OD plus metformin

  • Active comparator

    Insulin glargine OD plus metformin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Time frame · Week 0, week 26

    Registry description

    Change from baseline in HbA1c after 26 weeks of treatment

Secondary outcomes(2)

  1. Change From Baseline in Body Weight

    Time frame · Week 0, week 26

    Registry description

    Change from baseline in body weight after 26 weeks of treatment

  2. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

    Time frame · During 26 weeks of treatment

    Registry description

    Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with or without 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 26

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

GroupValue (Percentage (%))Spread
Insulin Degludec/Liraglutide (IDegLira)-1.811.08
Insulin Glargine (IGlar)-1.130.98
Secondary and other outcome results(2)
Secondary outcomeMean· Week 0, week 26

Change From Baseline in Body Weight

GroupValue (Kg)Spread
Insulin Degludec/Liraglutide (IDegLira)-1.43.5
Insulin Glargine (IGlar)1.83.6
Secondary outcomeNumber· During 26 weeks of treatment

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

GroupValue (Number of episodes)
Insulin Degludec/Liraglutide (IDegLira)289
Insulin Glargine (IGlar)683

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin Degludec/Liraglutide (IDegLira)Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.–5 / 27852 / 278
Insulin Glargine (IGlar)Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.–9 / 27922 / 279

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

Studies10

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2024

6 results

Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes.

Philis-Tsimikas et al. 2024Journal of diabetes science and technologycited by 8

PMID 36710452PMC11089877DOI 10.1177/19322968221149041PUB-36710452

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2019

6 results

EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES.

Lingvay et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 7

PMID 30383495DOI 10.4158/ep-2018-0284PUB-30383495

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2018

8 results

Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial.

Lingvay et al. 2018Diabetes, obesity & metabolismcited by 13

PMID 28643425PMC5763397DOI 10.1111/dom.13043PUB-28643425

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

Indexing hint: Randomized controlled trial · 2017

2 results

Evaluation of the long-term cost-effectiveness of IDegLira versus liraglutide added to basal insulin for patients with type 2 diabetes failing to achieve glycemic control on basal insulin in the USA.

Hunt et al. 2017Journal of medical economicscited by 19

PMID 28294641DOI 10.1080/13696998.2017.1301943PUB-28294641

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Observational study · 2017

4 results

Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used.

Norwood et al. 2017Diabetes, obesity & metabolismcited by 3

PMID 28417535PMC5655847DOI 10.1111/dom.12972PUB-28417535

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

More studies

4 studies on this page

PubMed tag: none · 2020

Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin.

Meneghini et al. 2020Diabetic medicine : a journal of the British Diabetic Associationcited by 5

PMID 31705547PMC7003817DOI 10.1111/dme.14178PUB-31705547

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2017

Corrected

Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Continued Up-Titration of Insulin Glargine U100 in Patients with Type 2 Diabetes in the USA.

Hunt et al. 2017Advances in therapycited by 13

PMID 28281218PMC5435780DOI 10.1007/s12325-017-0502-2PUB-28281218

Free to read · publisher termsCC BY-NC
Read at sourceRead the notice

PubMed tag: none · 2017

Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system.

Psota et al. 2017ClinicoEconomics and outcomes research : CEORcited by 10

PMID 29276398PMC5731336DOI 10.2147/ceor.s143127PUB-29276398

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2016

Corrected

Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial.

Lingvay et al. 2016JAMAcited by 175

PMID 26934259DOI 10.1001/jama.2016.1252PUB-26934259

Full text at the publisher
Publisher pageRead the notice

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 - HbA1c 7.0-10.0% \[53-86 mmol/mol\] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m\^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) 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 (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic acute pancreatitis

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